Clinical trial · Interventional
Colposcopy Versus HPV Testing to Identify Persistent Cervical Precancers
Randomized Controlled Trial Comparing Routine Colposcopy to HPV Testing to Identify Persistent or Recurrent High Grade Cervical Cancer Precursors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Cervical Intra-epithelial Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active comparator: Routine colposcopy | Other | — | UNRESOLVED |
| high risk HPV DNA testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HPV testing
- description
- Women randomized to this arm will undergo high risk HPV DNA testing using Hybrid Capture 2®.
- interventionNames
- Other: high risk HPV DNA testing
- type
- ACTIVE_COMPARATOR
- label
- Routine colposcopy
- description
- 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.
- interventionNames
- Other: Active comparator: Routine colposcopy
Primary outcomes (1)
- measure
- Sensitivity of HPV testing and sensitivity of routine colposcopy to identify CIN2 or worse disease after treatment for CIN 2/3
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available