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Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers

NCT01051895 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2253

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • High Grade Cervical Intra-epithelial Neoplasia

Interventions

OTHER

high risk HPV DNA testing

Specimens will be collected with a cervical cytobrush and cervical cells will be resuspended in 2 ml of Preservcyt® (Hologic LP), a liquid cytology preservation media. 75µl of processed sample will be hybridized with 25 µl of probe B mixture. The assay is completed as a standard enzyme immunoassay with the addition of a dioxetane-based chemiluminescent substrate. Specimens will be considered positive for HPV if the ratio of RLUs of the specimen to the mean RLUs of triplicates of positive control (at 1 pg per ml or 5000 copies of HPV genome per test) is at least one.

OTHER

Active comparator: Routine colposcopy

Women will undergo colposcopy, 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.

Sponsors & Collaborators

  • Terry Fox Foundation

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Marie-Hélène Mayrand, MD,PhD · Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2015-09-30
Completion
2027-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051895 on ClinicalTrials.gov