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NCT02864147 · ClinicalTrials.gov registry record · Phase 2
Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
NCT02864147: Completed Phase 2 study, sponsored by Yale University.
NCT02864147 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 134 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02864147, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
Study Summary
This is a randomized Phase II, three arm control trial in patients with Cervical Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3 meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study pathologist to confirm diagnosis. HPV DNA test and HPV 16/18 genotyping will be performed from endocervical cytobrush samples to determine HPV status associated with the dysplasia. Patients who have CIN 2/3 with HPV+ disease will be enrolled in this study. Patients will be randomized to one of three arms: observation only (control), imiquimod only, imiquimod + 9-valent HPV vaccine.
Primary Outcome
The major parameters of objective response to be assessed include treatment efficacy defined as histologic regression of cervical dysplasia to CIN 1 or less after the end of imiquimod treatment, HPV clearance and treatment tolerance. Objective response will be categorized as 'yes' or 'no' and included in the evaluations are the following criteria: * Histologic regression (HR): Histologic regression of all index lesions to CIN 1 or less after end of imiquimod treatment period. * Histologic remis
Interventions
- DRUG Imiquimod
- DRUG 9-valent HPV vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2016-07 |
| Est. Completion | 2022-11-22 |
| Phase | Phase 2 |
What the finished NCT02864147 record still lists
NCT02864147 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.
NCT02864147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02864147 about?
NCT02864147 is a clinical study titled "Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)". This is a randomized Phase II, three arm control trial in patients with Cervical Intraepithelial Neoplasia (CIN) 2/3 high grade cervical dysplasia. Patients with CIN 2/3 meeting eligibility criteria will have cervical biopsy specimens centrally reviewed by study pathologist to confirm diagnosis. HPV...
What is the current status of trial NCT02864147?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2016-07. Estimated completion is 2022-11-22.
What interventions are being tested in trial NCT02864147?
The interventions under investigation include: Imiquimod (DRUG), 9-valent HPV vaccine (DRUG).
Who is sponsoring clinical trial NCT02864147?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02864147's enrollment target sits among peer trials
134 537th of 2000 higher than 1,463 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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