Peter Kaatsch

Universitätsklinikum Freiburg, Freiburg an der Elbe, Lower Saxony, Germany

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Publications (193)645.36 Total impact

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    ABSTRACT: Some previous studies have suggested that home pesticide exposure before birth and during a child's early years may increase the risk of childhood leukemia. To further investigate this, we pooled individual level data from 12 case-control studies in the Childhood Leukemia International Consortium (CLIC). Exposure data were harmonized into compatible formats. Pooled analyses were undertaken using multivariable unconditional logistic regression. The odds ratio (ORs) for acute lymphoblastic leukaemia (ALL) associated with any pesticide exposure shortly before conception, during pregnancy and after birth were 1.39 (95% confidence interval (CI) 1.25, 1.55) (using (2,785 cases, 3635 controls), 1.43 (95% CI 1.32, 1.54) (5,055 cases, 7,370 controls) and 1.36 (95% CI 1.23, 1.51) (4,162 cases 5,179 controls), respectively. Corresponding ORs for risk of acute myeloid leukaemia (AML) were 1.49 (95% CI 1.02, 2.16) (173 cases, 1,789 controls), 1.55 (95% CI 1.21, 1.99) (344 cases, 4,666 controls) and 1.08 (95% CI 0.76, 1.53) (198 cases, 2,655 controls) respectively. There was little difference by type of pesticide used. The relative similarity in ORs between leukaemia types, time periods and pesticide types may be explained by similar exposure patterns and effects across the time periods in ALL and AML, participants' exposure to multiple pesticides, or recall bias. Although some recall bias is likely, until a better study design can be found to investigate associations between home pesticide use and childhood leukaemia in an equally large sample, it would appear prudent to limit the use of home pesticides before and during pregnancy, and during childhood. This article is protected by copyright. All rights reserved. © 2015 UICC.
    International Journal of Cancer 06/2015; DOI:10.1002/ijc.29631 · 5.01 Impact Factor
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    ABSTRACT: Cancer is relatively rare in childhood, but it contributes considerably to childhood mortality, years of life lost per person and late effects in survivors. Large populations need to be covered to set up meaningful studies of these rare conditions. Cancer registries ensure cancer surveillance, thus providing the basis for research as well as policy decisions. In this paper we examine coverage of childhood population by cancer registries in Europe and encourage national cancer registration. Over 200 cancer registries in various stages of development were identified as collecting data on childhood cancer patients in Europe. They cover 52% of the childhood population in the World Health Organisation (WHO) European region and 83% in the European Union (EU). More than 80% of this coverage is ensured by nationwide data collection, which is ongoing in 29 European countries. Overall coverage of the childhood population could increase to around 98%, if the recently established cancer registries start producing results and others improve their quality and dissemination plans. Paediatric cancer registries are being established with increasing frequency even in the areas covered by general cancer registries, and they tend to be national. Compared with regional registration, national cancer registries are more cost-effective, record larger number of cases, they can achieve higher completeness, less biased incidence and survival estimates and they are conditioned for national and international research. National registration of childhood cancer should be the rule in Europe, so that accurate regional, nation-wide and international statistics can provide solid baselines for research, clinical practice and public health policy. Governmental support and stakeholders' involvement are indispensable to guarantee optimal data quality and completeness. Copyright © 2015 Elsevier Ltd. All rights reserved.
    European journal of cancer (Oxford, England: 1990) 04/2015; 51(9). DOI:10.1016/j.ejca.2015.03.009 · 4.82 Impact Factor
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    ABSTRACT: With the advent of multimodality therapy, the overall five-year survival rate from childhood cancer has improved considerably now exceeding 80% in developed European countries. This growing cohort of survivors, with many years of life ahead of them, has raised the necessity for knowledge concerning the risks of adverse long-term sequelae of the life-saving treatments in order to provide optimal screening and care and to identify and provide adequate interventions. Childhood cancer survivor cohorts in Europe. Considerable advantages exist to study late effects in individuals treated for childhood cancer in a European context, including the complementary advantages of large population-based cancer registries and the unrivalled opportunities to study lifetime risks, together with rich and detailed hospital-based cohorts which fill many of the gaps left by the large-scale population-based studies, such as sparse treatment information. Several large national cohorts have been established within Europe to study late effects in individuals treated for childhood cancer including the Nordic Adult Life after Childhood Cancer in Scandinavia study (ALiCCS), the British Childhood Cancer Survivor Study (BCCSS), the Dutch Childhood Oncology Group (DCOG) LATER study, and the Swiss Childhood Cancer Survivor Study (SCCSS). Furthermore, there are other large cohorts, which may eventually become national in scope including the French Childhood Cancer Survivor Study (FCCSS), the French Childhood Cancer Survivor Study for Leukaemia (LEA), and the Italian Study on off-therapy Childhood Cancer Survivors (OTR). In recent years significant steps have been taken to extend these national studies into a larger pan-European context through the establishment of two large consortia - PanCareSurFup and PanCareLIFE. The purpose of this paper is to present an overview of the current large, national and pan-European studies of late effects after childhood cancer. This overview will highlight the strong cooperation across Europe, in particular the EU-funded collaborative research projects PanCareSurFup and PanCareLIFE. Overall goal. The overall goal of these large cohort studies is to provide every European childhood cancer survivor with better care and better long-term health so that they reach their full potential, and to the degree possible, enjoy the same quality of life and opportunities as their peers.
    Acta oncologica (Stockholm, Sweden) 03/2015; DOI:10.3109/0284186X.2015.1008648 · 3.71 Impact Factor
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    ABSTRACT: Little is known about the relationship between family characteristics and survival from childhood acute lymphoblastic leukaemia (ALL), which we studied for the first time in German children. ALL cases were diagnosed between 1992 and 1994 and information on family characteristics was collected during a previously conducted nationwide case-control study. Children were followed for 10 years after diagnosis, as few disease-related events occur afterwards. Cox proportional hazards models estimating hazard ratios (HR) were calculated using overall as well as event-free survival methods. Second born children showed statistically significant better survival compared to first or later born children, with HRs ranging between 0.54 and 0.64 compared to firstborns. Somewhat poorer survival was observed for children having 3 or more siblings. A relationship was found for parental age at child's diagnosis, with poorer survival for children with younger parents (≤25 years of age at child's diagnosis), or with older fathers. The HR was statistically significant for fathers being ≥41years of age (HR of 2.1). No relationship between degree of urbanization of the place of residence at diagnosis and ALL survival was observed. Family circumstances may have an impact on survival from childhood ALL in Germany. Further research is warranted to elaborate the relationship of specific family characteristics and ALL survival and to investigate possible differential adherence to therapy and interactions with physicians. Copyright © 2015 Elsevier Ltd. All rights reserved.
    Cancer Epidemiology 02/2015; 39(2). DOI:10.1016/j.canep.2015.01.012 · 2.56 Impact Factor
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    ABSTRACT: Malignant germ cell tumors (GCTs) are a rare and a heterogeneous group of pediatric cancers. The incidence rate has increased in some populations or subgroups. However, only a few recent publications on epidemiologic data showing the trends in incidence of pediatric GCTs are available. We analyzed the incidence rates, time trends, and survival for 1366 GCTs in children 0 to 14 years old registered in the nationwide, population-based German Childhood Cancer Registry in 1987-2011. The incidence rate of GCTs was slightly higher in girls (age-standardized rate: girls, 5.3; boys, 4.4 per million). A bimodal age distribution was seen. In children aged <1 year, the highest age-specific incidence rates were seen for girls with GCTs in the pelvis (12.7 per million) and for boys with GCTs in the testis (9.5 per million). For 10- to 14-year-old boys, the tumors occurred most often in the central nervous system (3.1 per million); for girls, the most common site was in the ovaries (4.5 per million). Only the incidence rate for ovarian GCTs increased statistically significantly. The 5- and 20-year survival probabilities for the patients diagnosed between 1987 and 2010 were 92% and 90%, respectively. Survival rates improved notably for intracranial and extragonadal GCTs from 1987 to 2006. The localization and histology of the GCTs varied between the genders and age groups. During 1987 to 2011, the incidence rate increased only for ovarian GCTs. The increase, however, may be due to changes in reporting. The survival rates were excellent. Copyright © 2015 by the American Academy of Pediatrics.
    Pediatrics 12/2014; 135(1). DOI:10.1542/peds.2014-1989 · 5.30 Impact Factor
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    ABSTRACT: Maternal occupational pesticide exposure during pregnancy and/or paternal occupational pesticide exposure around conception have been suggested to increase risk of leukemia in the offspring. With a view to providing insight in this area we pooled individual level data from 13 case-control studies participating in the Childhood Leukemia International Consortium (CLIC). Occupational data were harmonized to a compatible format. Pooled individual analyses were undertaken using unconditional logistic regression. Using exposure data from mothers of 8,236 cases, and 14,850 controls, and from fathers of 8,169 cases and 14,201 controls the odds ratio (OR) for maternal exposure during pregnancy and the risk of acute lymphoblastic leukemia (ALL) was 1.01 (95% confidence interval (CI) 0.78, 1.30) and for paternal exposure around conception 1.20 (95% 1.06, 1.38). For acute myeloid leukemia (AML), the OR for maternal exposure during pregnancy was 1.94 (CI 1.19, 3.18) and for paternal exposure around conception 0.91 (CI 0.66, 1.24.) based on data from 1,329 case and 12,141 control mothers, and 1,231 case and 11,383 control fathers. Our finding of a significantly increased risk of AML in the offspring with maternal exposure to pesticides during pregnancy is consistent with previous reports. We also found a slight increase in risk of ALL with paternal exposure around conception which appeared to be more evident in children diagnosed at the age of five years or more and those with T cell ALL which raises interesting questions on possible mechanisms. © 2014 Wiley Periodicals, Inc.
    International Journal of Cancer 11/2014; 25(10). DOI:10.1002/ijc.28854 · 5.01 Impact Factor
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    ABSTRACT: Higher childhood cancer incidence rates are generally reported for high income countries although high quality information on descriptive patterns of childhood cancer incidence for low or middle income countries is limited, particularly in Sub-Saharan Africa. There is a need to quantify global differences by cancer types, and to investigate whether they reflect true incidence differences or can be attributed to under-diagnosis or under-reporting. For the first time, we describe childhood cancer data reported to the pathology report-based National Cancer Registry South Africa in 2000 – 2006 and compare our results to incidence data from Germany, a high income country. The overall age-standardized incidence rate (ASR) for South Africa in 2000-2006 was 45.7 per million children. We observed substantial differences by cancer types within South Africa by racial group; ASRs tended to be 3-4-fold higher in South African Whites compared to Blacks. ASRs among both Black and White South Africans were generally lower than those from Germany with the greatest differences observed between the Black population in South Africa and Germany, although there was marked variation between cancer types. Age-specific rates were particularly low comparing South African Whites and Blacks with German infants. Overall, patterns across South African population groups and in comparison to Germans were similar for boys and girls. Genetic and environmental reasons may probably explain rather a small proportion of the observed differences. More research is needed to understand the extent to which under-ascertainment and under-diagnosis of childhood cancers drives differences in observed rates. © 2014 Wiley Periodicals, Inc.
    International Journal of Cancer 11/2014; 136(11). DOI:10.1002/ijc.29308 · 5.01 Impact Factor
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    ABSTRACT: To assess the risk of childhood central nervous system (CNS) tumors associated with parental occupational exposure to polycyclic aromatic hydrocarbons (PAH), diesel motor exhaust (DME), asbestos, crystalline silica, and metals, which are established carcinogens in adults.
    Cancer Causes and Control 10/2014; DOI:10.1007/s10552-014-0465-4 · 2.96 Impact Factor
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    ABSTRACT: Background: Maternal prenatal supplementation with folic acid and other vitamins has been inconsistently associated with a reduced risk of childhood acute lymphoblastic leukemia (AL). Little is known regarding the association with acute myeloid leukemia (AML), a rarer subtype. Methods: We obtained original data on prenatal use of folic acid and vitamins from 12 case-control studies participating in the Childhood Leukemia International Consortium (enrollment period: 1980-2012), including 6,963 cases of AL, 585 cases of AML, and 11,635 controls. Logistic regression was used to estimate pooled odds ratios (ORs) and 95% confidence intervals (CIs), adjusted for child's age, sex, ethnicity, parental education, and study center. Results: Maternal supplements taken any time before conception or during pregnancy were associated with a reduced risk of childhood AL; odds ratios were 0.85 (95% CI = 0.78-0.92) for vitamin use and 0.80 (0.71-0.89) for folic acid use. The reduced risk was more pronounced in children whose parents' education was below the highest category. The analyses for AML led to somewhat unstable estimates; ORs were 0.92 (0.75-1.14) and 0.68 (0.48-0.96) for prenatal vitamins and folic acid, respectively. There was no strong evidence that risks of either types of leukemia varied by period of supplementation (preconception, pregnancy, or trimester). Conclusions: Our results, based on the largest number of childhood leukemia cases to date, suggest that maternal prenatal use of vitamins and folic acid reduces the risk of both AL and AML and that the observed association with AL varied by parental education, a surrogate for lifestyle and sociodemographic characteristics.
    Epidemiology (Cambridge, Mass.) 09/2014; 25(6). DOI:10.1097/EDE.0000000000000141 · 6.18 Impact Factor
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    ABSTRACT: Recent findings related to childhood leukaemia incidence near nuclear installations have raised questions which can be answered neither by current knowledge on radiation risk nor by other established risk factors. In 2012, a workshop was organised on this topic with two objectives: (a) review of results and discussion of methodological limitations of studies near nuclear installations; (b) identification of directions for future research into the causes and pathogenesis of childhood leukaemia. The workshop gathered 42 participants from different disciplines, extending widely outside of the radiation protection field. Regarding the proximity of nuclear installations, the need for continuous surveillance of childhood leukaemia incidence was highlighted, including a better characterisation of the local population. The creation of collaborative working groups was recommended for consistency in methodologies and the possibility of combining data for future analyses. Regarding the causes of childhood leukaemia, major fields of research were discussed (environmental risk factors, genetics, infections, immunity, stem cells, experimental research). The need for multidisciplinary collaboration in developing research activities was underlined, including the prevalence of potential predisposition markers and investigating further the infectious aetiology hypothesis. Animal studies and genetic/epigenetic approaches appear of great interest. Routes for future research were pointed out.
    Journal of Radiological Protection 06/2014; 34(3):R53. DOI:10.1088/0952-4746/34/3/R53 · 1.32 Impact Factor
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    ABSTRACT: Radiotherapy (RT) has been associated with the development of solid second malignant neoplasms (SMNs) in childhood cancer survivors. The aim of this study was to analyse the effect of cumulative doses of previous RT received at the SMN body region, at all other body regions and at body regions adjacent to the SMN, on the risk of developing a solid SMN. A total of 190 cases diagnosed with a solid second malignant neoplasm in 1980-2002 were matched with 368 controls with single neoplasm from the database of the German Childhood Cancer Registry (GCCR) (33,809 patients at cut-off date). The GCCR registers approximately 97 % of all childhood malignancies which occur at an age of less than 15 years in Germany since 1980. It was found that 147 (77.4 %) cases had received RT compared to 208 (56.6 %) controls with cumulative focus doses from 8 to 110 Gy. Fifty per cent of the SMNs and 60 % of RT affected the head region. RT was shown to increase the risk of a solid second tumour within the body region of radiation by 5.3 % per Gy (odds ratio 1.053; 95 % confidence interval 1.036-1.071). With increasing age at diagnosis and with more recent treatment eras, this effect decreased. Cumulative RT doses received at all other body regions or only at body regions adjacent to the SMN did not show an additional effect on the risk of developing an SMN. It is thus concluded that RT is the main risk factor for the development of SMNs within the irradiated body region. Late effects surveillance of former patients should give special attention to the originally irradiated parts of the body.
    Biophysik 05/2014; 53(3). DOI:10.1007/s00411-014-0550-9 · 1.58 Impact Factor
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    ABSTRACT: The German Childhood Cancer Registry (GCCR) annually registers approximately 2,000 children diagnosed with a malignant disease (completeness of registration >95%). While most pediatric cancer patients are diagnosed and treated according to standardized cooperative protocols of the German Society for Pediatric Oncology and Hematology (GPOH), patients with rare tumors are at risk of not being integrated in the network including trials and reference centers. A retrospective analysis of all rare extracranial solid tumors reported to the GCCR 2001-2010 (age <18 years) was undertaken using a combination of the International Classification of Childhood Cancer (ICCC-3) and the International Classification of Diseases-Oncology (ICD-O-3). Tumors accounting for <0.3% of all malignancies were defined as rare (approx. 6 cases/year and registered malignancy). According to this definition 1,189 rare extracranial solid tumors (18.2% of all malignant extracranial solid tumors) were registered, among these 232 patients (19.5% of rare tumor cases), were not included in preexisting GPOH studies/registries. Within 10 years, the number of registered non-GPOH-trial patients with a rare tumor increased. Though most of the GCCR-registered patients with rare malignant tumors are treated within GPOH trials, there is a considerable number of patients that have been diagnosed and treated outside the structures of the GPOH. These patients should be reported to the recently founded German Pediatric Rare Tumor Registry (STEP). Active data accrual and the development of appropriate structures will allow for better registration and improvement of medical care in these patients. Pediatr Blood Cancer © 2014 Wiley Periodicals, Inc.
    Pediatric Blood & Cancer 02/2014; 61(7). DOI:10.1002/pbc.24997 · 2.56 Impact Factor
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    ABSTRACT: Sex, age, immunophenotype and white blood cell count at diagnosis are well accepted predictors of survival from acute lymphoblastic leukaemia (ALL) in children. Less is known about the relationship between socio-economic determinants and survival from paediatric ALL, studied here for the first time in German children. ALL cases were diagnosed between 1992 and 1994 and their parents interviewed during a previous nationwide case-control study. Children were followed-up for 10years after diagnosis by the German Childhood Cancer Registry. Cox proportional hazards models estimating hazard ratios (HRs) were calculated to assess the impact of selected socio-demographic characteristics on overall and event-free survival. Overall survival was 82.5%, with a higher proportion of girls than boys surviving (85% versus 81%). We found a non-linear relationship between age at diagnosis and survival, with poorer survival in infants and children aged >5years. There was no association between socio-economic factors and survival or risk of relapse. For five levels of increasing family income, all HRs were close to one. No relationship was seen with parental educational level. Socio-economic determinants did not affect ALL survival in West German children, in contrast to studies from some other countries. Dissimilarities in social welfare systems, including access to health care, lifestyle and differences in treatment may contribute to these differences in findings. Our observation of no social inequalities in paediatric ALL survival is reassuring, but needs continued monitoring to assess the potential impact of evolvement of treatment options and changes in paediatric health service.
    European journal of cancer (Oxford, England: 1990) 02/2014; DOI:10.1016/j.ejca.2014.01.028 · 4.82 Impact Factor
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    ABSTRACT: Summary Background Survival and cure rates for childhood cancers in Europe have greatly improved over the past 40 years and are mostly good, although not in all European countries. The EUROCARE-5 survival study estimates survival of children diagnosed with cancer between 2000 and 2007, assesses whether survival differences among European countries have changed, and investigates changes from 1999 to 2007. Methods We analysed survival data for 157 499 children (age 0—14 years) diagnosed between Jan 1, 1978 and Dec 31, 2007. They came from 74 population-based cancer registries in 29 countries. We calculated observed, country-weighted 1-year, 3-year, and 5-year survival for major cancers and all cancers combined. For comparison between countries, we used the corrected group prognosis method to provide survival probabilities adjusted for multiple confounders (sex, age, period of diagnosis, and, for all cancers combined without CNS cancers, casemix). Age-adjusted survival differences by area and calendar period were calculated with period analysis and were given for all cancers combined and the major cancers. Findings We analysed 59 579 cases. For all cancers combined for children diagnosed in 2000—07, 1-year survival was 90·6% (95% CI 90·2—90·9), 3-year survival was 81·0 % (95% CI 80·5—81·4), and 5-year survival was 77·9% (95% CI 77·4—78·3). For all cancers combined, 5-year survival rose from 76·1% (74·4—77·7) for 1999—2001, to 79·1% (77·3—80·7) for 2005—07 (hazard ratio 0·973, 95% CI 0·965—0·982, p<0·0001). The greatest improvements were in eastern Europe, where 5-year survival rose from 65·2% (95% CI 63·1—67·3) in 1999—2001, to 70·2% (67·9—72·3) in 2005—07. Europe-wide average yearly change in mortality (hazard ratio) was 0·939 (95% CI 0·919—0·960) for acute lymphoid leukaemia, 0·959 (0·933—0·986) for acute myeloid leukaemia, and 0·940 (0·897—0·984) for non-Hodgkin lymphoma. Mortality for all of Europe did not change significantly for Hodgkin's lymphoma, Burkitt's lymphoma, CNS tumours, neuroblastoma, Wilms' tumour, Ewing's sarcoma, osteosarcoma, and rhabdomyosarcoma. Disparities for 5-year survival persisted between countries and regions, ranging from 70% to 82% (for 2005—07). Interpretation Several reasons might explain persisting inequalities. The lack of health-care resources is probably most important, especially in some eastern European countries with limited drug supply, lack of specialised centres with multidisciplinary teams, delayed diagnosis and treatment, poor management of treatment, and drug toxicity. In the short term, cross-border care and collaborative programmes could help to narrow the survival gaps in Europe. Funding Italian Ministry of Health, European Commission, Compagnia di San Paolo Foundation.
    The Lancet Oncology 12/2013; DOI:10.1016/S1470-2045(13)70548-5 · 24.73 Impact Factor
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    ABSTRACT: In Germany and Austria, more than 90% of pediatric cancer patients are enrolled into nationwide disease-specific first-line clinical trials or interim registries. Essential components are a pediatric cancer registry and centralized reference laboratories, imaging review, and tumor board assistance. The five-year overall survival rate in countries where such infrastructures are established has improved from <20% before 1950 to >80% since 1995. Today, treatment intensity is tailored to the individual patient's risk to provide the highest chances of survival while minimizing deleterious late effects. Multicenter clinical trials are internationalized and serve as platforms for further improvements by novel drugs and biologicals. Pediatr Blood Cancer 2013;9999:1-8. © 2013 Wiley Periodicals, Inc.
    Pediatric Blood & Cancer 10/2013; 60(10). DOI:10.1002/pbc.24598 · 2.56 Impact Factor
  • Cancer Research 08/2013; 73(8 Supplement):LB-31-LB-31. DOI:10.1158/1538-7445.AM2013-LB-31 · 9.28 Impact Factor
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    ABSTRACT: Positive associations have been reported between measures of accelerated fetal growth and risk of childhood acute lymphoblastic leukemia (ALL). We investigated this association by pooling individual-level data from 12 case-control studies participating in the Childhood Leukemia International Consortium. Two measures of fetal growth - weight-for-gestational-age and proportion of optimal birth weight (POBW) - were analysed. Study-specific odds ratios (ORs) and 95% confidence intervals (CIs) were estimated using multivariable logistic regression, and combined in fixed effects meta-analyses. Pooled analyses of all data were also undertaken using multivariable logistic regression. Subgroup analyses were undertaken when possible. Data on weight for gestational age were available for 7,348 cases and 12,489 controls from all 12 studies and POBW data were available for 1,680 cases and 3,139 controls from three studies. The summary ORs from the meta-analyses were 1.24 (95% CI 1.13, 1.36) for children who were large for gestational age relative to appropriate for gestational age, and 1.16 (95% CI: 1.09, 1.24) for a one standard deviation increase in POBW. The pooled analyses produced similar results. The summary and pooled ORs for small-for-gestational-age children were 0.83 (95% CI: 0.75, 0.92) and 0.86 (95% CI 0.77, 0.95) respectively. Results were consistent across subgroups defined by sex, ethnicity and immunophenotype, and when the analysis was restricted to children who did not have high birth weight. The evidence that accelerated fetal growth is associated with a modest increased risk of childhood ALL is strong and consistent with known biological mechanisms involving insulin like growth factors. © 2013 Wiley Periodicals, Inc.
    International Journal of Cancer 07/2013; 133(12). DOI:10.1002/ijc.28314 · 5.01 Impact Factor
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    ABSTRACT: BACKGROUND: Ensuring adequate parental consent is a key issue of ethical practice in pediatric oncology. In Germany, however, knowledge about parental comprehension and satisfaction with the informed consent procedure is limited, and representative data on parents' perspectives are still missing. Based on data collected by means of a population-based survey, we evaluated the parental recall of the informed consent process for pediatric clinical trials, and how they rated the consent process retrospectively. PROCEDURE: A standardized survey was carried out among 1,465 parents whose children were first diagnosed in 2005 with a disease defined by ICCC-3 in the German Childhood Cancer Registry (response: 55.1%). The survey's primary objective was to assess how well parents were able to recall of the informed consent process. To evaluate the results, we set up a second survey among 581 parents who had given consent recently for their child's participation in a clinical trial (response: 53.5%). RESULTS: Approximately 81% of the parents in the population-based survey correctly remembered whether or not their child had been enrolled in a clinical trial or treated off-trial. The ability to recall accurately is significantly lower if the parents have a migration background or if their child was not a trial participant. However, parents who recalled the child's trial participation status incorrectly felt as adequately informed as parents who recalled it correctly. CONCLUSIONS: Our results identified weak points and vulnerable subgroups in the parental consent process in pediatric oncology in Germany. Pediatr Blood Cancer © 2012 Wiley Periodicals, Inc.
    Pediatric Blood & Cancer 03/2013; 60(3). DOI:10.1002/pbc.24330 · 2.56 Impact Factor
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    ABSTRACT: Background: Acute leukemia is the most common cancer in children under 15 years of age; 80% are acute lymphoblastic leukemia (ALL) and 17% are acute myeloid leukemia (AML). Childhood leukemia shows further diversity based on cytogenetic and molecular characteristics, which may relate to distinct etiologies. Case-control studies conducted worldwide, particularly of ALL, have collected a wealth of data on potential risk factors and in some studies, biospecimens. There is growing evidence for the role of infectious/immunologic factors, fetal growth, and several environmental factors in the etiology of childhood ALL. The risk of childhood leukemia, like other complex diseases, is likely to be influenced both by independent and interactive effects of genes and environmental exposures. While some studies have analyzed the role of genetic variants, few have been sufficiently powered to investigate gene-environment interactions. Objectives: The Childhood Leukemia International Consortium (CLIC) was established in 2007 to promote investigations of rarer exposures, gene-environment interactions and subtype-specific associations through the pooling of data from independent studies. Methods: By September 2012, CLIC included 22 studies (recruitment period: 1962-present) from 12 countries, totaling approximately 31000 cases and 50000 controls. Of these, 19 case-control studies have collected detailed epidemiologic data, and DNA samples have been collected from children and child-parent trios in 15 and 13 of these studies, respectively. Two registry-based studies and one study comprising hospital records routinely obtained at birth and/or diagnosis have limited interview data or biospecimens. Conclusions: CLIC provides a unique opportunity to fill gaps in knowledge about the role of environmental and genetic risk factors, critical windows of exposure, the effects of gene-environment interactions and associations among specific leukemia subtypes in different ethnic groups.
    02/2013; 37(3). DOI:10.1016/j.canep.2012.12.011
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    ABSTRACT: Background. Ensuring adequate parental consent is a key issue of ethical practice in pediatric oncology. In Germany, however, knowledge about parental comprehension and satisfaction with the informed consent procedure is limited, and representative data on parents’ perspectives are still missing. Based on data collected by means of a population-based survey, we evaluated the parental recall of the informed consent process for pediatric clinical trials, and how they rated the consent process retrospectively. Procedure. A standardized survey was carried out among 1,465 parents whose children were first diagnosed in 2005 with a disease defined by ICCC-3 in the German Childhood Cancer Registry (response: 55.1%). The survey’s primary objective was to assess how well parents were able to recall of the informed consent process. To evaluate the results, we set up a second survey among 581 parents who had given consent recently for their child’s participation in a clinical trial (response: 53.5%). Results. Approximately 81% of the parents in the population-based survey correctly remembered whether or not their child had been enrolled in a clinical trial or treated off-trial. The ability to recall accurately is ignificantly lower if the parents have a migration background or if their child was not a trial participant. However, parents who recalled the child’s trial participation status incorrectly felt as adequately informed as parents who recalled it correctly. Conclusions. Our results identified weak points and vulnerable subgroups in the parental consent process in pediatric oncology in Germany.

Publication Stats

5k Citations
645.36 Total Impact Points

Institutions

  • 2013–2015
    • Universitätsklinikum Freiburg
      Freiburg an der Elbe, Lower Saxony, Germany
  • 1990–2015
    • Johannes Gutenberg-Universität Mainz
      • Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI)
      Mayence, Rheinland-Pfalz, Germany
  • 2012–2013
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Institute for Medical Biometry, Epidemiology and Computer Science
      Mayence, Rheinland-Pfalz, Germany
  • 2010
    • Universität Ulm
      • Clinic of Pediatric and Adolescent Medicine
      Ulm, Baden-Württemberg, Germany
  • 2009
    • German Cancer Research Center
      • Division of Clinical Epidemiology and Aging Research
      Heidelberg, Baden-Wuerttemberg, Germany
    • Istituto Superiore di Sanità
      • National Centre for Epidemiology, Surveillance and Health Promotion
      Roma, Latium, Italy
    • Universität Basel
      Bâle, Basel-City, Switzerland
    • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
      • Dipartimento di Medicina Predittiva e per la Prevenzione
      Milano, Lombardy, Italy
    • Centro di Riferimento per l'Epidemiologia e la Prevenzione Oncologica in Piemonte
      Torino, Piedmont, Italy
  • 2005
    • Gemeinschaftskrankenhaus Herdecke
      Herdecke, North Rhine-Westphalia, Germany
  • 2004
    • Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V.
      Mayence, Rheinland-Pfalz, Germany
  • 2001
    • German Institute Of Medical Documentation And Information
      Köln, North Rhine-Westphalia, Germany
  • 1996
    • Universität zu Lübeck
      • Department of Paediatrics
      Lübeck Hansestadt, Schleswig-Holstein, Germany
  • 1994
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
      باد کروزینگن, Baden-Württemberg, Germany
  • 1989
    • University of Iowa Children's Hospital
      Iowa City, Iowa, United States