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HPV Testing vs Colposcopy for Cervical Dysplasia (CoHIPP Trial)

N/A

Waitlist Available

Led By Marie-Hélène Mayrand, MD,PhD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Woman ≥ 18 years old (19 in British Columbia, Nova Scotia and Newfoundland)

Is treated for biopsy proven CIN II, III or AIS

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare HPV testing to the routine colposcopy in follow-up for women treated for cervical high grade lesions. Women will be randomly assigned to follow-up by colposcopy or HPV testing, and those with disease will be offered re-treatment. This will be assessed over 2 years with yearly, in depth, evaluation to compare which strategy worked best.

Who is the study for?

This trial is for women over 18 who have been treated for high-grade cervical lesions, understand English or French, and can sign the consent form. It's not for those planning a hysterectomy, on recent immunosuppressive therapy, with a history of cervical cancer treatment, or unlikely to follow the study plan.

What is being tested?

The trial compares two methods to monitor women after treatment for cervical pre-cancer: routine colposcopy versus HPV DNA testing. Participants will be randomly assigned to one of these strategies and followed up yearly for 2 years to see which method is more effective.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, side effects are minimal but may include discomfort from colposcopy or anxiety from waiting for test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman over the age of 18 (19 in specific regions).

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I am being treated for a confirmed case of CIN II, III, or AIS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken corticosteroids in the last two weeks.

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I have taken corticosteroids twice or more in the last year for at least a week each time.

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I have a known immune system problem.

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I am scheduled for a hysterectomy.

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I have been treated for cervical cancer or pre-cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HPV testingExperimental Treatment1 Intervention

Women randomized to this arm will undergo high risk HPV DNA testing using Hybrid Capture 2®.

Group II: Routine colposcopyActive Control1 Intervention

Women will be followed in the colposcopy clinic as usual, with no standardized protocol, tests are left at the discretion of the treating physician, in order to document routine proactive. We will document all procedures (biopsies, endocervical curettage, cytology, etc) and their outcome.

0 / 7Eligibility criteria met