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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post treatment

Awards & highlights

CoHIPP Trial 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.Check my eligibility

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.See study design

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.

CoHIPP Trial 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.

CoHIPP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensitivity of HPV testing and sensitivity of routine colposcopy to identify CIN2 or worse disease after treatment for CIN 2/3

Secondary outcome measures

The area under the respective ROC curves (HPV testing and routine colposcopy)

CoHIPP 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 / 2Eligibility criteria met

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Who is running the clinical trial?

Terry Fox FoundationOTHER

7 Previous Clinical Trials

2,182 Total Patients Enrolled

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

127,384 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,343 Previous Clinical Trials

26,450,840 Total Patients Enrolled

Media Library

Routine colposcopy Clinical Trial Eligibility Overview. Trial Name: NCT01051895 — N/A

Cervical Neoplasia Research Study Groups: HPV testing, Routine colposcopy

Cervical Neoplasia Clinical Trial 2023: Routine colposcopy Highlights & Side Effects. Trial Name: NCT01051895 — N/A

Routine colposcopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01051895 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for enrollees in this research trial?

"According to the information hosted on clinicaltrials.gov, this trial is not presently enrolling patients. It was initially posted in 2010 and last updated November 18th 2022. Although no participants are being sought for this particular study, there are 2414 other medical trials actively recruiting individuals currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers

2010. "Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01051895.