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Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
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.
Official title: Randomized Controlled Trial Comparing Routine Colposcopy to HPV Testing to Identify Persistent or Recurrent High Grade Cervical Cancer Precursors
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2253
Start Date
2010-01
Completion Date
2027-12
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
Centre de recherche du CHUM
Montreal, Quebec, Canada