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 range18 Years

SexFEMALE

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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.

What they're measuring

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)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09