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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 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 134 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02864147
The ClinicalTrials.gov registry entry for NCT02864147 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.
NCT02864147 reports 0 study locations.
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.
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