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Antiplatelet Agent
Omeprazole + Aspirin for Colorectal Cancer
Phase < 1
Recruiting
Led By Zora Djuric
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a prior history of colorectal neoplasia including history of incompletely resected colorectal polyp(s) (adenoma or sessile serrated polyp) on most recent colonoscopy
Have a prior history of colorectal neoplasia including multiple (>=5) colorectal adenomas on most recent colonoscopy
Must not have
Have a history of prior aspirin or NSAID gastritis with bleeding
Currently taking medications associated with increased risk for bleeding (warfarin, Eliquis, Plavix, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 45 days from intervention initiation
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the effects of omeprazole and low-dose aspirin in preventing colorectal issues in individuals with specific colorectal conditions. Eligible participants will take omeprazole
Who is the study for?
This trial is for people who've had at least 5 adenomas or serrated polyps, or an incompletely removed one in the colon/rectum. They must consent to daily medication and two tissue biopsies during colon exams.
What is being tested?
The study tests if omeprazole (40 mg) and low-dose aspirin (162 mg) taken daily can prevent colorectal cancer by looking for changes in biomarkers from tissue samples before and after treatment.
What are the potential side effects?
Possible side effects include stomach pain, heartburn, nausea from omeprazole; bleeding risk, gastrointestinal issues like ulcers from aspirin; discomfort or risks associated with biopsy procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had colorectal polyps that were not completely removed.
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I have had 5 or more polyps found in my last colonoscopy.
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I have had 5 or more sessile serrated polyps found in my last colonoscopy.
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I am between 18 and 75 years old.
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I have a history of a specific type of colon polyps known as serrated polyps.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had stomach issues with bleeding from aspirin or NSAIDs before.
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I am currently on medication that increases my risk of bleeding.
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I am not taking any medications that interact with omeprazole.
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I have a bleeding disorder such as hemophilia or Von Willebrand disease.
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I have genetic mutations linked to colon cancer risk.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 45 days from intervention initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 45 days from intervention initiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum
Secondary study objectives
Evaluation of gene expression changes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment2 Interventions
Two 20 mg/day omeprazole tablets and two 81 mg/day aspirin tablets taken before the first meal each day for 25-45 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omeprazole
2006
Completed Phase 4
~940
Aspirin
2014
Completed Phase 4
~55580
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
21,211 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,093 Total Patients Enrolled
Zora DjuricPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center