Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Eduardo L.F. Franco


Contact details

Division of Cancer Epidemiology
McGill University
546 Pine Avenue West
H2W 1S6
+1 514 398 6032

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Efficacy trial of human papillomavirus (HPV) versus Pap testing for screening cervical cancer precursors: a randomised controlled trial



Study hypothesis

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

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

More information can be found at


High-grade cervical intra-epithelial neoplasia


Pap testing compared to HPV testing.

Intervention type



Not Applicable

Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


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 type


Age group




Target number of participants

10,154 randomised into trial

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


Recruitment end date



Countries of recruitment


Trial participating centre

Division of Cancer Epidemiology
H2W 1S6

Sponsor information


McGill University (Canada) - Research Grants Office

Sponsor details

845 Sherbrooke Street West
James Administration Bldg.
Suite 429
H3A 2T5
+1 514 398 3996

Sponsor type




Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - (ref: MCT-54063)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Merck-Frosst (Canada) - unrestricted educational grant

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 protocol on
2. 2007 results on

Publication citations

  1. Protocol

    Mayrand MH, Duarte-Franco E, Coutlée F, Rodrigues I, Walter SD, Ratnam S, Franco EL, , Randomized controlled trial of human papillomavirus testing versus Pap cytology in the primary screening for cervical cancer precursors: design, methods and preliminary accrual results of the Canadian cervical cancer screening trial (CCCaST)., Int. J. Cancer, 2006, 119, 3, 615-623, doi: 10.1002/ijc.21897.

  2. Results

    Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, Ratnam S, Coutlée F, Franco EL, , Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer., N. Engl. J. Med., 2007, 357, 16, 1579-1588, doi: 10.1056/NEJMoa071430.

Editorial Notes