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Samuel Ratnam,
Francois Coutlee,
Dan Fontaine,
James Bentley,
Nicholas Escott,
Prafull Ghatage,
Veeresh Gadag,
Glen Holloway,
Elias Bartellas,
Nick Kum, Christopher Giede,
Adrian Lear
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ABSTRACT: Detection of human papillomavirus (HPV) E6/E7 oncogene expression may be more predictive of cervical cancer risk than testing for HPV DNA. The Aptima HPV test (Gen-Probe) detects E6/E7 mRNA of 14 oncogenic types. Its clinical performance was compared with that of the Hybrid Capture 2 DNA test (HC2; Qiagen) in women referred for colposcopy and those routinely screened. Aptima was also compared with the PreTect HPV-Proofer E6/E7 mRNA assay (Proofer; Norchip) in the referral population. Cervical specimens collected in PreservCyt (Hologic Inc.) were processed for HPV detection and genotyping with the Linear Array (LA) method (Roche Molecular Diagnostics, Laval, Quebec, Canada). Histology-confirmed high-grade cervical intraepithelial neoplasia (CIN 2) or worse (CIN 2+) served as the disease endpoint. On the basis of 1,418 referral cases (CIN 2+, n = 401), the sensitivity of Aptima was 96.3% (95% confidence interval [CI], 94.4, 98.2), whereas it was 94.3% (95% CI, 92.0, 96.6) for HC2. The specificities were 43.2% (95% CI, 40.2, 46.2) and 38.7% (95% CI, 35.7, 41.7), respectively (P < 0.05). In 1,373 women undergoing routine screening (CIN 2+, n = 7), both Aptima and HC2 showed 100% sensitivity, and the specificities were 88.3% (95% CI, 86.6, 90.0) and 85.3% (95% CI, 83.5, 87.3), respectively (P < 0.05); for women ≥ 30 years of age (n = 845), the specificities were 93.9% (95% CI, 92.3, 95.5) and 92.1% (95% CI, 90.3, 93.9), respectively (P < 0.05). On the basis of 818 referral cases (CIN 2+, n = 235), the sensitivity of Aptima was 94.9% (95% CI, 92.1, 97.7) and that of Proofer was 79.1% (95% CI, 73.9, 84.3), and the specificities were 45.8% (95% CI, 41.8, 49.8) and 75.1% (95% CI, 71.6, 78.6), respectively (P < 0.05). Both Aptima and Proofer showed a higher degree of agreement with LA genotyping than HC2. In conclusion, the Aptima test is as sensitive as HC2 but more specific for detecting CIN 2+ and can serve as a reliable test for both primary cervical cancer screening and the triage of borderline cytological abnormalities.
Journal of clinical microbiology 02/2011; 49(2):557-64. · 4.16 Impact Factor
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Laurie M Elit,
Barry Rosen,
Waldo Jimenez, Christopher Giede,
Paulina Cybulska,
Sarah Sinasac,
Jason Dodge,
Erdenejargal Ayush,
Orango Omenge,
Marcus Bernardini,
Sarah Finlayson,
Jessica McAlpine,
Dianne Miller
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ABSTRACT: With the widespread implementation of screening programs internationally, there will be an increase in early stage cervical cancer cases. In response to this, the Ministry of Health in each country will need to plan strategies to provide care such as radical surgery or radiation for this potentially curable group of women.
The Gynaecologic Oncologists of Canada created a teaching module to intensively train a small number of locally identified gynecologists to perform radical hysterectomy and pelvic lymphadenectomy. The process was based on adult learning principles; it involved a Canadian gynecologic oncologist working in the low- or middle-resource country with the gynecologists and problem-solving local issues in health care delivery.
The teaching process included a pretest and a posttest on the basis of the objectives of the module. There were 7 modules including preoperative evaluation of the patient, cone biopsy, radical hysterectomy, pelvic lymphadenectomy, ureteric injury, vascular injury, and follow-up after surgery. Each module was divided into background information, techniques, and complications. There were video clips imbedded in the modules. After the educational modules had been reviewed, the learners were walked through the surgical procedures repeatedly including a detailed assessment of performance after each case. Participants had the opportunity to provide feedback on the training program. The module was reviewed in Mongolia and implemented in Kenya.
In low- and middle-resource countries where there is an urgent need to provide a curative surgical option for the management of early cervical cancer, a focused high-intensity curriculum delivered by a trained surgeon can translate into immediate change in clinical and surgical practice.
International Journal of Gynecological Cancer 12/2010; 20(9):1604-8. · 1.65 Impact Factor
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Samuel Ratnam,
Francois Coutlee,
Dan Fontaine,
James Bentley,
Nicholas Escott,
Prafull Ghatage,
Veeresh Gadag,
Glen Holloway,
Elias Bartellas,
Nick Kum, Christopher Giede,
Adrian Lear
[show abstract]
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ABSTRACT: Human papillomavirus (HPV) DNA testing has a higher clinical sensitivity than cytology for the detection of high-grade cervical intraepithelial neoplasia or worse (CIN 2+). However, an improvement in specificity would be desirable. As malignant transformation is induced by HPV E6/E7 oncogenes, detection of E6/E7 oncogene activity may improve specificity and be more predictive of cervical cancer risk. The PreTect HPV-Proofer assay (Proofer; Norchip) detects E6/E7 mRNA transcripts from HPV types 16, 18, 31, 33, and 45 with simultaneous genotype-specific identification. The clinical performance of this assay was assessed in a cross-sectional study of women referred for colposcopy in comparison with the Hybrid Capture 2 (HC2; Qiagen) test, which detects DNA of 13 high-risk oncogenic HPV types collectively. Cervical specimens were collected in PreservCyt, and cytology was performed using the ThinPrep method (Hologic). The samples were processed for HPV detection with Proofer and HC2 and genotyping with the Linear Array method (Roche Molecular Systems). Histology-confirmed CIN 2+ served as the disease endpoint to assess the clinical performance of the tests. A total of 1,551 women were studied, and of these, 402 (25.9%) were diagnosed with CIN 2+ on histology. The Proofer assay showed a sensitivity of 78.1% (95% confidence interval [CI], 74.1 to 82.1) versus 95.8% (95% CI, 93.8 to 97.8) for HC2 (P < 0.05) and a specificity of 75.5% (95% CI, 73.0 to 78.0) versus 39.6% (95% CI, 36.8 to 42.4), respectively (P < 0.05). The lower sensitivity and higher specificity of Proofer for detection of CIN 2+ can be attributed to the fact that this test detects the expression of E6/E7 genes beyond a threshold from a limited number of oncogenic HPV types. In conclusion, Proofer is more specific than HC2 in identifying women with CIN 2+ but has a lower sensitivity.
Journal of clinical microbiology 08/2010; 48(8):2779-85. · 4.16 Impact Factor
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ABSTRACT: Women attending the University of Saskatchewan Student Health Services are being offered human papillomavirus (HPV) vaccination but are not filling their prescriptions. We sought to identify gaps in knowledge of the link between HPV infection, cervical dysplasia, and cervical cancer among women attending the Student Health Services, and to identify barriers to HPV vaccination among this cohort of women.
Women attending the University of Saskatchewan Student Health Services for any reason were invited to complete an 18-question survey. The survey included questions regarding knowledge of the purpose of Pap smears, the role of HPV infection in cervical dysplasia and cancer, and HPV vaccination. The questions were designed to elicit both quantitative and qualitative data. Data analysis included basic descriptive analysis and summarization of qualitative data.
Four hundred surveys were distributed, and 371 (91%) were returned. Eighty-two percent of participants were aware of the HPV vaccine, and 40% ranked their knowledge of HPV as good or very good; however, only 6% correctly answered questions about methods of preventing HPV infection. Participants identified cost (62%), concerns over adverse effects (43%), and lack of knowledge (36%) as barriers to undergoing vaccination. Comments about the HPV vaccine reflected frustration with cost and concerns about adverse effects. When participants were asked if they would undergo vaccination if it were free, 60% responded "yes," 31% responded "maybe," and 8% responded "no."
The young women in our survey had significant gaps in knowledge of HPV infection and prevention, and educational programs must be structured to address these deficits. Institutions promoting vaccination must deal with the barriers of cost and fear of adverse effects.
Journal of obstetrics and gynaecology Canada: JOGC = Journal d'obstetrique et gynecologie du Canada: JOGC 07/2010; 32(7):679-86.
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Tien Le, Christopher Giede,
Shia Salem,
Guylaine Lefebvre,
Barry Rosen,
James Bentley,
Rachel Kupets,
Patti Power,
Marie-Claude Renaud,
Peter Bryson, [......],
Lucie Morin,
Stephen Bly,
Kimberly Butt,
Yvonne M Cargill,
Nanette Denis,
Robert Gagnon,
Marja Anne Hietala-Coyle,
Kenneth Ian Lim,
Annie Ouellet,
Maria-Hélène Raciot
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ABSTRACT: To optimize the management of adnexal masses and to assist primary care physicians and gynaecologists determine which patients presenting with an ovarian mass with a significant risk of malignancy should be considered for gynaecologic oncology referral and management.
Laparoscopic evaluation, comprehensive surgical staging for early ovarian cancer, or tumour debulking for advanced stage ovarian cancer.
To optimize conservative versus operative management of women with possible ovarian malignancy and to optimize the involvement of gynaecologic oncologists in planning and delivery of treatment.
Published literature was retrieved through searches of PubMed or MEDLINE, CINAHL, and the Cochrane Library, using appropriate controlled vocabulary and key words. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Grey (unpublished) literature was identified by searching the web sites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies.
1. Primary care physicians and gynaecologists should always consider the possibility of an underlying ovarian cancer in patients in any age group who present with an adnexal or ovarian mass. (II-2B) 2. Appropriate workup of a perimenopausal or postmenopausal woman presenting with an adnexal mass should include evaluation of symptoms and signs suggestive of malignancy, such as persistent pelvic/abdominal pain, urinary urgency/frequency, increased abdominal size/bloating, and difficulty eating. In addition, CA125 measurement should be considered. (II-2B) 3. Transvaginal or transabdominal ultrasound examination is recommended as part of the initial workup of a complex adnexal/ovarian mass. (II-2B) 4. Ultrasound reports should be standardized to include size and unilateral/bilateral location of the adnexal mass and its possible origin, thickness of septations, presence of excrescences and internal solid components, vascular flow distribution pattern, and presence or absence of ascites. This information is essential for calculating the risk of malignancy index II score to identify pelvic mass with high malignant potential. (IIIC) 5. Patients deemed to have a high risk of an underlying malignancy should be reviewed in consultation with a gynaecologic oncologist for assessment and optimal surgical management. (II-2B).
Journal of obstetrics and gynaecology Canada: JOGC = Journal d'obstetrique et gynecologie du Canada: JOGC 07/2009; 31(7):668-80.
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ABSTRACT: The goal of this study was to review our experience with transrectal ultrasound (TRUS)-guided biopsies in women with a pelvic mass, with respect to obtaining an adequate sample, the influence of biopsy results on patient management, and patient tolerance.
We conducted a chart review of all women at the Princess Margaret Hospital (PMH) that had been clinically referred for TRUS-guided biopsies of a pelvic mass. Data collected included patient age, previous type of malignancy, size and location of lesion being biopsied, postbiopsy diagnosis, and subsequent management. Statistics were purely descriptive.
Eight women have had this procedure at PMH. The smallest size of lesion biopsied was 1.7 x 1.4 x 2.3 cm. In all eight women, the tissue obtained was adequate for the determination of a histological diagnosis and subsequently influenced patient management. The procedure was well tolerated and there were no complications.
TRUS-guided biopsy of a pelvic mass is a feasible method of establishing a pathological diagnosis. In this small series of patients, it was found to be accurate, well tolerated, and useful in guiding patient management. In selected patients, the TRUS biopsy provides a useful alternative to transabdominal and transvaginal biopsy.
Gynecologic Oncology 01/2005; 95(3):552-6. · 3.89 Impact Factor
