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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 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 70 participants.

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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.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER placebo
  • OTHER questionnaire administration
  • DRUG chemoprevention

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2007-09-04
Est. Completion 2014-09-17
Phase Phase 1

What the Registry Record Tells You About NCT01469429

The ClinicalTrials.gov registry entry for NCT01469429 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT01469429 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.