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NCT02023931 · ClinicalTrials.gov registry record · Early Phase 1
Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa
A Early Phase 1 study of Healthy Subject, sponsored by Julie E. Bauman, MD, MPH.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT02023931: Completed Early Phase 1 study of Healthy Subject, sponsored by Julie E. Bauman, MD, MPH.
NCT02023931 is a Early Phase 1 study of Healthy Subject that has completed, run by Julie E. Bauman, MD, MPH. The registered enrollment target is 10 participants, below the 247-participant average among 16 other Healthy Subject trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02023931, a Early Phase 1 study of Healthy Subject, has completed, sponsored by Julie E. Bauman, MD, MPH.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
A pilot study has been designed to determine (primary objective) if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data and preliminary effect size for specific Nrf2 targets, as measured in serial buccal cell scrapings, will be determined during the course of 3-day exposures to three BSE regimens. These data will inform the design of a randomized, phase II chemoprevention trial in patients with HPV-negative HNSCC. Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear Institute or the Hillman Cancer Center. This may include patients with benign disease or their friends/family members, or friends/family members of patients with cancer; 2) Professionals, staff, or students at the University of Pittsburgh.
Primary Outcome
The primary objective is limited to obtaining preliminary estimates of Nrf2 pathway modulation from buccal cell specimens samples all collected during each of the three 5 day intervention periods. Endpoints include mRNA transcript levels of certain genes or enzymes regulated by Nrf2. Note that the goals of this study are limited to obtaining initial pharmacodynamic estimates of Nrf2 pathway modulation for each BSE intervention. Accordingly, no hypothesis testing or comparative analyses are plan
Conditions Studied
Interventions
- DRUG Broccoli Sprout Extract (BSE)
Study Locations (2)
Pennsylvania
- Eye and Ear Institute - Pittsburgh
- UPMC Hillman Cancer Center (University of Pittsburgh Cancer Institute) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-01 |
| Phase | Early Phase 1 |
What the finished NCT02023931 record still lists
NCT02023931 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 247-participant average among 16 other Healthy Subject trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy Subject appearing as the primary indexed condition, and to 1 intervention - of which Broccoli Sprout Extract (BSE) is the first listed.
NCT02023931 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02023931 about?
NCT02023931 is a clinical study titled "Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa". A pilot study has been designed to determine (primary objective) if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data and preliminary effec...
What is the current status of trial NCT02023931?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2014-03. Estimated completion is 2015-01.
What conditions does trial NCT02023931 study?
This clinical trial studies the following conditions: Healthy Subject.
What interventions are being tested in trial NCT02023931?
The interventions under investigation include: Broccoli Sprout Extract (BSE) (DRUG).
Who is sponsoring clinical trial NCT02023931?
This trial is sponsored by Julie E. Bauman, MD, MPH, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02023931 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02023931's enrollment target sits among peer trials
10 17th of 16 the lowest of 16 other Healthy Subject trials
participants (enrollment target), bucketed by value
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