The Canadian Cervical Cancer Screening Trial of human papillomavirus (HPV) testing versus Pap cytology
| ISRCTN | ISRCTN57612064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57612064 |
| Secondary identifying numbers | MCT-54063 |
- Submission date
- 09/09/2005
- Registration date
- 09/09/2005
- Last edited
- 05/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Eduardo L.F. Franco
Scientific
Scientific
Division of Cancer Epidemiology
McGill University
546 Pine Avenue West
Montreal
H2W 1S6
Canada
| Phone | +1 514 398 6032 |
|---|---|
| eduardo.franco@mcgill.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | More information can be found at http://www.mcgill.ca/cccast/ |
| Scientific title | Efficacy trial of human papillomavirus (HPV) versus Pap testing for screening cervical cancer precursors: a randomised controlled trial |
| Study acronym | CCCaST |
| 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. |
| Ethics approval(s) | 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. |
| Condition | High-grade cervical intra-epithelial neoplasia |
| Intervention | Pap testing compared to HPV testing. |
| Intervention type | Other |
| Primary outcome measure | Biopsy-proven cervical intraepithelial neoplasia (CIN 2, 3) (high grade intraepithelial lesion [HSIL]) or cancer, ascertained at 6, 12, and 18 months |
| Secondary outcome measures | Biopsy-proven CIN 1 (low grade intraepithelial lesion [LSIL]) at 18 months. |
| Overall study start date | 26/09/2002 |
| Overall study end date | 31/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 10,154 randomised into trial |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 26/09/2002 |
| Recruitment end date | 31/07/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Division of Cancer Epidemiology
Montreal
H2W 1S6
Canada
H2W 1S6
Canada
Sponsor information
McGill University (Canada) - Research Grants Office
University/education
University/education
845 Sherbrooke Street West
James Administration Bldg., Suite 429
Montreal
H3A 2T5
Canada
| Phone | +1 514 398 3996 |
|---|---|
| janine.vasseur@mcgill.ca | |
| Website | http://www.mcgill.ca/ |
"ROR" |
https://ror.org/01pxwe438 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-54063)
No information available
Merck-Frosst (Canada) - unrestricted educational grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/08/2006 | Yes | No | |
| Results article | results | 18/10/2007 | Yes | No |
