protocolSection identificationModule nctId: NCT06378398, orgStudyIdInfo id: UMCC 2023.037, secondaryIdInfos id: HUM00247729, type: OTHER, domain: University of Michigan, secondaryIdInfos id: UMI23-13-01, type: OTHER, domain: DCP Protocol Number, secondaryIdInfos id: 1UG1CA242632-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1UG1CA242632-01A1, briefTitle: A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Michigan Rogel Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Colorectal Neoplasia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Omeprazole, interventions name: Aspirin, outcomesModule primaryOutcomes measure: Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum, secondaryOutcomes measure: Evaluation of gene expression changes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Michigan Rogel Cancer Center, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Kirsten Tuck, role: CONTACT, phone: 734-763-1141, email: KLtuck@med.umich.edu, contacts name: Elena Stoffel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Kebire Gofar, role: CONTACT, email: Kebire.Gofar@osumc.edu, contacts name: Peter Stanich, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False