Colorectal NeoplasiaEarly Phase 1NCT06378398
A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy
A Early Phase 1 study testing Omeprazole and Aspirin in people with Colorectal Neoplasia, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasia
- What is being tested?
- Omeprazole and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2024to 17 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- Individuals who are due for a standard of care colonoscopy.
- Have a prior history of colorectal neoplasia including any ONE of the following:
- Multiple (>=5) colorectal adenomas on most recent colonoscopy
- Multiple (>=5) sessile serrated polyps on most recent colonoscopy
- Adenomatous polyps meeting criteria for colon polyposis of unknown etiology (> 20 lifetime adenomas)
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- Serrated polyps meeting criteria for serrated polyposis syndrome
- History of incompletely resected colorectal polyp(s) (adenoma or sessile serrated polyp) on most recent colonoscopy
- Willing to avoid taking non-steroidal anti-inflammatory drugs that are not provided by the study in the 30 days prior to Visit 1 and while on study.
- Willing to avoid taking proton pump inhibitors that are not provided by the study in the 30 days prior to Visit 1 and while on study.
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation since endoscopy is not recommended during pregnancy.
- Demonstrate adequate organ and marrow function obtained within the last 60 days as defined below:
- Absolute neutrophil count ≥1,000/microliter
- Platelets ≥100,000/microliter
- Total bilirubin ≤ 1.5 fold of the institutional upper limit of normal Note: Higher total bilirubin levels (≤ 3 mg/dL) can be allowed if due to known benign liver condition such as Gilbert's
- AST (SGOT)/ALT (SGPT) ≤3.0 fold of the institutional upper limit of normal
- Creatinine ≤1.5 fold of the institutional upper limit of normal
- Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Age 76 or higher since there is an increased risk of GI bleeding and peptic ulcer disease in persons above 75 years of age.
- Pathogenic germline variants in adenomatous polyposis coli (APC) and DNA mismatch repair (MMR) genes associated with Lynch Syndrome, or biallelic pathogenic germline variants in the MutY homologue glycosylase (MUTYH) gene.
- Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to proton pump inhibitors and/or aspirin.
- Participants may not be receiving any other investigational agents.
- Have a history of prior aspirin or NSAID gastritis with bleeding.
- Currently taking a proton pump inhibitor and unable/unwilling to discontinue use 30 days prior to Visit 1.
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- Taking NSAIDs or aspirin >25% of the time (>8 days/month) and unable/unwilling to discontinue use 30 days prior to Visit 1 and until Visit 4.
- Currently taking medications associated with increased risk for bleeding (warfarin, Eliquis, Plavix, etc.).
- Currently taking medications that have interactions with omeprazole: atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, sparsentan, certain azole antifungals (itraconazole, ketoconazole, and posaconazole).
- Have a history of hemophilia, Von Willebrand disease or any other known bleeding diathesis.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Individuals who the site physician investigator assesses as at high risk for bleeding due to heavy alcohol use or comorbid conditions.
- Pregnant women are excluded since endoscopy is not recommended while pregnant.
- Have invasive cancer or being treated for invasive cancer at the current time or within the past 36 months, with the exception of cancers curatively removed by surgery, other than melanoma, and stage I and II cervical squamous cell cancers.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
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
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.
Read the detailed description
JAN2025 amendment added Adenomatous polyps meeting criteria for colon polyposis of unknown etiology (> 20 lifetime adenomas)
- Conditions
- Colorectal Neoplasia
- Being tested
- Omeprazole, Aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec
Two 20 mg/day omeprazole tablets taken before the first meal each day for 25-45 days.
AspirinDrug
Also called Bayer Aspirin
Two 81 mg/day aspirin tablets taken before the first meal each day for 25-45 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Two 20 mg/day omeprazole tablets and two 81 mg/day aspirin tablets taken before the first meal each day for 25-45 days. Receives: Drug: Omeprazole; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum
The ratio of Ki67 proliferation marker to cleaved caspase 3 apoptosis marker, and changes in gene expression by high throughput RNA sequencing (RNA-Seq).
Measured: up to 45 days from intervention initiation
Secondary outcomes (1)
Evaluation of gene expression changes
To compare gene expression changes by RNA-Seq observed in the clinical trial with that observed in a well-characterized rodent colon cancer prevention model to evaluate potential for preventive efficacy.
Measured: up to 45 days from intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start14 Jun 2024
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zora Djuric, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378398
- Sponsor's protocol ID
- UMCC 2023.037
- Other IDs
- HUM00247729, UMI23-13-01, 1UG1CA242632-01A1
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06378398
- Acronym / sponsor ID
- UMCC 2023.037
- Conditions
- Colorectal Neoplasia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
JAN2025 amendment added Adenomatous polyps meeting criteria for colon polyposis of unknown etiology (> 20 lifetime adenomas)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Omeprazole, Drug: AspirinTwo 20 mg/day omeprazole tablets and two 81 mg/day aspirin tablets taken before the first meal each day for 25-45 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age 18-75
- Individuals who are due for a standard of care colonoscopy.
- Have a prior history of colorectal neoplasia including any ONE of the following:
- Willing to avoid taking non-steroidal anti-inflammatory drugs that are not provided by the study in the 30 days prior to Visit 1 and while on study.
- Willing to avoid taking proton pump inhibitors that are not provided by the study in the 30 days prior to Visit 1 and while on study.
Key exclusion criteria (14 listed)
- Age 76 or higher since there is an increased risk of GI bleeding and peptic ulcer disease in persons above 75 years of age.
- Pathogenic germline variants in adenomatous polyposis coli (APC) and DNA mismatch repair (MMR) genes associated with Lynch Syndrome, or biallelic pathogenic germline variants in the MutY homologue glycosylase (MUTYH) gene.
- Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to proton pump inhibitors and/or aspirin.
- Participants may not be receiving any other investigational agents.
- Have a history of prior aspirin or NSAID gastritis with bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: PrilosecTwo 20 mg/day omeprazole tablets taken before the first meal each day for 25-45 days. | Drug | Intervention |
| AspirinAlso: Bayer AspirinTwo 81 mg/day aspirin tablets taken before the first meal each day for 25-45 days. | Drug | Intervention |
Primary outcome
Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum
Time frame: up to 45 days from intervention initiation
The ratio of Ki67 proliferation marker to cleaved caspase 3 apoptosis marker, and changes in gene expression by high throughput RNA sequencing (RNA-Seq).
1 secondary outcome
Evaluation of gene expression changes
Time frame: up to 45 days from intervention initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Only aggregate data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zora Djuric principal investigator
University of Michigan Rogel Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omeprazole and Aspirin in people with Colorectal Neoplasia, run by University of Michigan Rogel Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum (time frame: up to 45 days from intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.