Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers

NCT01051895 | Active Not Recruiting DMC

• 1 other identifier: 09.078
• Study Type: interventional
• Target: 2,253
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cervical intra-epithelial neoplasia; Colposcopy; HPV DNA testing; treatment failure

Outcome Measures

Primary Outcomes (1)

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

  6 months post treatment

Secondary Outcomes (1)

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

  6 months post treatment

Study Arms (2)

HPV testing

EXPERIMENTAL

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

Other: high risk HPV DNA testing

Routine colposcopy

ACTIVE COMPARATOR

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.

Other: Active comparator: Routine colposcopy

Interventions

high risk HPV DNA testing OTHER

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.

Also known as: Hybrid Capture 2®

HPV testing

Active comparator: Routine colposcopy OTHER

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.

Routine colposcopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Terry Fox Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre de recherche du CHUM

Montreal, Quebec, H2X 0A9, Canada

Location

Study Officials

• Marie-Hélène Mayrand, MD,PhD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2010
• First Posted: January 20, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2015
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (1)