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NCT01469429 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT01469429: Completed Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT01469429 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01469429, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
This randomized phase I/II trial studies the side effects and best way to give lyophilized black raspberries in preventing oral cancer in high-risk patients previously diagnosed with stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lyophilized black raspberries may prevent oral cancer. Studying samples of oral cavity scrapings, blood, urine, and saliva in the laboratory from patients receiving lyophilized black raspberries may help doctors learn more about changes that occur in DNA and the effect of lyophilized back raspberries on biomarkers.
Primary Outcome
Use diaries and collection of "empties" over 6-month treatment period. Test both measures simultaneously using global test. Two measures tested individually at alpha=0.05 if global test is significant. First check for interaction effect between dose and delivery with double-sided test at alpha=0.01. If that isn't significant, use data from both doses to perform a double-sided alpha=0.05 on difference in compliance between delivery methods. Dose response effect in compliance also tested. Explorin
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- OTHER questionnaire administration
- DRUG chemoprevention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2007-09-04 |
| Est. Completion | 2014-09-17 |
| Phase | Phase 1 |
What the finished NCT01469429 record still lists
NCT01469429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01469429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01469429 about?
NCT01469429 is a clinical study titled "Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.". This randomized phase I/II trial studies the side effects and best way to give lyophilized black raspberries in preventing oral cancer in high-risk patients previously diagnosed with stage I-IV or in situ head and neck cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. ...
What is the current status of trial NCT01469429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2007-09-04. Estimated completion is 2014-09-17.
What interventions are being tested in trial NCT01469429?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), questionnaire administration (OTHER), chemoprevention (DRUG).
Who is sponsoring clinical trial NCT01469429?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01469429's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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