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22 May 2012
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| [ Print-friendly version ] |
| The Canadian Cervical Cancer Screening Trial of human papillomavirus (HPV) testing versus Pap cytology |
| ISRCTN | ISRCTN57612064 |
| ClinicalTrials.gov identifier | |
| Public title | The Canadian Cervical Cancer Screening Trial of human papillomavirus (HPV) testing versus Pap cytology |
| Scientific title | Efficacy trial of human papillomavirus (HPV) versus Pap testing for screening cervical cancer precursors: a randomised controlled trial |
| Acronym | CCCaST |
| Serial number at source | MCT-54063 |
| Study hypothesis |
Objectives:
1. To compare human papillomavirus (HPV) testing with Pap cytology to detect prevalent and early incident asymptomatic cervical cancers and their high-grade precancerous lesions among women aged 30 - 69 years who present for their routine cervical cancer screening in Montreal and Newfoundland 2. To identify individual, social, and health care delivery variables that influence the performance of the Pap smear and of HPV testing and determine the costs of delivery of those two screening strategies in the two populations chosen for the study As of 05/01/2010 this record was updated; all details can be found under the relevant section with the above update date. At this point, the target number of participants field was also updated; the initial target number of participants at time of registration was 12,000. However, 14,953 women were assessed for eligibility and invited to participate and 10,154 were randomised into the trial. |
| Lay summary | |
| Ethics approval | Ethics approval received from the Institutional Review Board of McGill University on the 26th April 2005. Ethics approval has been extended to several additional clinics and institutions involved in the study. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | High-grade cervical intra-epithelial neoplasia |
| Participants - inclusion criteria |
Current inclusion criteria as of 05/01/2010:
1. Women aged 30 to 69 years 2. Sought screening tests for cervical cancer in any of 30 family practice or gynaecology clinics in Montreal and St. John's, Canada Initial inclusion criteria at time of registration: 1. Women aged between 30 and 69 years 2. Currently attending a colposcopy clinic for evaluation, treatment or follow up of a cervical lesion |
| Participants - exclusion criteria |
Current exclusion criteria as of 05/01/2010:
1. Currently being followed up for a cervical lesion 2. Lacked a cervix 3. Pregnant 4. Had a history of cervical cancer 5. Had undergone Pap testing in the previous year 6. Unable to provide consent were excluded (note that this is related also to the ability to understand French or English) Initial exclusion criteria at time of registration: 1. Without a cervix 2. Pregnant 3. History of cervical cancer 4. Known human immunodeficiency virus (HIV) infection 5. Mentally incompetent 6. Unable to understand French or English 7. Refuse to provide an informed consent |
| Anticipated start date | 26/09/2002 |
| Anticipated end date | 31/07/2007 |
| Status of trial | Completed |
| Patient information material | More information can be found at http://www.mcgill.ca/cccast/ |
| Target number of participants | 10,154 randomised into trial |
| Interventions | Pap testing compared to HPV testing. |
| Primary outcome measure(s) | Biopsy-proven cervical intraepithelial neoplasia (CIN 2, 3) (high grade intraepithelial lesion [HSIL]) or cancer, ascertained at 6, 12, and 18 months |
| Secondary outcome measure(s) | Biopsy-proven CIN 1 (low grade intraepithelial lesion [LSIL]) at 18 months. |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-54063)
2. Merck-Frosst (Canada) - unrestricted educational grant |
| Trial website | http://www.mcgill.ca/cccast/ |
| Publications |
1. 2006 protocol on http://www.ncbi.nlm.nih.gov/pubmed/16572425
2. 2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17942871 |
| Contact name | Prof Eduardo L.F. Franco |
| Address |
Division of Cancer Epidemiology
McGill University 546 Pine Avenue West |
| City/town | Montreal |
| Zip/Postcode | H2W 1S6 |
| Country | Canada |
| Tel | +1 514 398 6032 |
| Fax | +1 514 398 5002 |
| eduardo.franco@mcgill.ca | |
| Sponsor | McGill University (Canada) - Research Grants Office |
| Address |
845 Sherbrooke Street West
James Administration Bldg., Suite 429 |
| City/town | Montreal |
| Zip/Postcode | H3A 2T5 |
| Country | Canada |
| Tel | +1 514 398 3996 |
| Fax | +1 514 398 3594 |
| janine.vasseur@mcgill.ca | |
| Sponsor website: | http://www.mcgill.ca/ |
| Date applied | 09/09/2005 |
| Last edited | 05/01/2010 |
| Date ISRCTN assigned | 09/09/2005 |
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