Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378398
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-04-17
Brief Title:
A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
An Early Phase 1 Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy The Omeprazole and Aspirin Polyp Prevention Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 participants clinical scenario Biopsies of both normal mucosa and polyps if possible are collected
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 participants clinical scenario Biopsies of both normal mucosa and polyps if possible are collected
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HUM00247729 | OTHER | None | None |
| UMI23-13-01 | OTHER | None | None |
| 1UG1CA242632-01A1 | NIH | DCP Protocol Number | httpsreporternihgovquickSearch1UG1CA242632-01A1 |