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The Canadian Cervical Cancer Screening Trial of human papillomavirus (HPV) testing versus Pap cytology
ISRCTN ISRCTN57612064
DOI 10.1186/ISRCTN57612064
ClinicalTrials.gov identifier
EudraCT number
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
  Email 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
  Email 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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