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NCT00330382 · ClinicalTrials.gov registry record · Phase 2
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 325
- Enrollment target
NCT00330382: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00330382 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 325 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00330382, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 325 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients with oral leukoplakia
Primary Outcome
Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area.
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- DRUG Bowman-Birk inhibitor concentrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 1999-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT00330382 record still lists
NCT00330382 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (144% higher).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT00330382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00330382 about?
NCT00330382 is a clinical study titled "Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia". This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a s...
What is the current status of trial NCT00330382?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 325 participants. The study started on 1999-01. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00330382?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), Bowman-Birk inhibitor concentrate (DRUG).
Who is sponsoring clinical trial NCT00330382?
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 NCT00330382's enrollment target sits among peer trials
325 148th of 2000 higher than 1,852 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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