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NCT06378398 · ClinicalTrials.gov registry record · Early Phase 1
A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy
A Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 21
- Enrollment target
NCT06378398: Completed Early Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.
NCT06378398 is a Early Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 21 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06378398, a Early Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. Before participating in the study, study staff will explain the study and review the consent form. If you are interested and provide consent, study staff will then confirm your eligibility. Once enrolled, participants will take two 20 mg omeprazole tablets and two 81 mg aspirin tablets each day before the first meal each day for 25-45 days. The study does involve biopsies of the colorectal tissue before and after taking the study medications. The biopsies are samples of tissue, about the size of a grain of rice, that will be taken from the colon or rectum before and after taking the study medications. This is done during a usual, clinical colonoscopy exam and during one more limited exam, called flexible sigmoidoscopy, that is done for the research study. The flexible sigmoidoscopy requires less preparation. Which procedure comes first depends on what fits best with each participant's clinical scenario. Biopsies of both normal mucosa and polyps (if possible) are collected.
Primary Outcome
The ratio of Ki67 proliferation marker to cleaved caspase 3 apoptosis marker, and changes in gene expression by high throughput RNA sequencing (RNA-Seq).
Interventions
- DRUG Aspirin
- DRUG Omeprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2024-06-14 |
| Est. Completion | 2026-02-17 |
| Phase | Early Phase 1 |
What the finished NCT06378398 record still lists
NCT06378398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Aspirin is the first listed.
NCT06378398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06378398 about?
NCT06378398 is a clinical study titled "A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy". This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. ...
What is the current status of trial NCT06378398?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 21 participants. The study started on 2024-06-14. Estimated completion is 2026-02-17.
What interventions are being tested in trial NCT06378398?
The interventions under investigation include: Aspirin (DRUG), Omeprazole (DRUG).
Who is sponsoring clinical trial NCT06378398?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06378398's enrollment target sits among peer trials
21 1130th of 2000 higher than 845 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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