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NCT03196180 · ClinicalTrials.gov registry record · Early Phase 1
Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
NCT03196180: Completed Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT03196180 is a Early Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03196180, a Early Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This early phase I clinical trial studies the side effects of topical fluorouracil and imiquimod ointment in treating patients with high-grade cervical intraepithelial neoplasia. Topical fluorouracil may kill precancerous cells. Imiquimod ointment may stimulate the immune system. Applying topical fluorouracil and imiquimod ointment may cause fewer side effects and may be a better way to treat patients with precancerous cervical lesions.
Primary Outcome
Feasibility is evaluated based on safety and tolerability of the study intervention. For safety, the study assessed the number of participants experiencing the specified adverse events defined as Grade 2 or greater toxicity (or Grade 1 toxicity of any genital lesion (blisters, ulcerations, or pustules)) that is possibly, probably, or definitely related and lasts for more than 5 days. For tolerability, the study assessed the number of participants who were not able to apply at least 50% of the tr
Interventions
- DRUG Imiquimod
- DRUG Topical Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2024-08-02 |
| Phase | Early Phase 1 |
What the finished NCT03196180 record still lists
NCT03196180 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.
NCT03196180 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03196180 about?
NCT03196180 is a clinical study titled "Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia". This early phase I clinical trial studies the side effects of topical fluorouracil and imiquimod ointment in treating patients with high-grade cervical intraepithelial neoplasia. Topical fluorouracil may kill precancerous cells. Imiquimod ointment may stimulate the immune system. Applying topical fl...
What is the current status of trial NCT03196180?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2019-10-15. Estimated completion is 2024-08-02.
What interventions are being tested in trial NCT03196180?
The interventions under investigation include: Imiquimod (DRUG), Topical Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT03196180?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03196180's enrollment target sits among peer trials
13 1503rd of 2000 higher than 472 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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