Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers (NCT01051895) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers
Canada2,253 participantsStarted 2010-01
Plain-language summary
This trial will compare HPV testing to the routine colposcopy in the follow-up of women treated for cervical high grade lesions. Women will be assigned randomly (by chance) after treatment of cervical pre-cancer to be either (1) followed-up by colposcopy, or (2) undergo HPV testing. Women found to have disease by either strategy will be offered re-treatment. For the next 2 years participants will undergo yearly, in depth, evaluation to assess the cervix for precancer. We will then be able to compare which of the 2 follow-up strategies worked best.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman ≥ 18 years old 19 in British Columbia, Nova Scotia and Newfoundland)
* Understands English or French (for sites where French speaking coordinator is available)
* Is treated for biopsy proven CIN II, III or AIS
* Understands study procedures, available alternatives treatment, risks related to study, and accepts voluntarily to participate by signing the ICF.
Exclusion Criteria:
* has been treated for cervical cancer or pre-cancer in the past
* Participant has known immunosuppression or immunodeficiency
* Planned hysterectomy
* Participant is receiving or has received one of the following treatment :
* Immunosuppressive therapy in the three months prior to enrollment
* Corticosteroid therapy in the two weeks prior to enrollment
* Two or more courses of corticosteroids (orally or parenterally) lasting at least one week in duration in the year prior to enrollment (inhalation, nasal or topical corticosteroids are permitted)
* There is a strong probability that the participant will not follow the procedures of study, will not come to its appointment, or plans a delocalization throughout study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of HPV testing and sensitivity of routine colposcopy to identify CIN2 or worse disease after treatment for CIN 2/3
Timeframe: 6 months post treatment
Trial details
NCT IDNCT01051895
SponsorCentre hospitalier de l'Université de Montréal (CHUM)