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Antiplatelet Agent

Intervention for Colorectal Cancer

Phase < 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 45 days from intervention initiation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 days from intervention initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum

Secondary outcome measures

Evaluation of gene expression changes

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

294 Previous Clinical Trials

24,237 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,680 Previous Clinical Trials

40,928,495 Total Patients Enrolled

Zora DjuricPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals younger than 45 years old participate in this research investigation?

"Participants eligible for this research project must be aged between 18 and 75 years old. Notably, there are a substantial number of studies available for individuals under 18 (325) as well as those over 65 (2406)."

Answered by AI

Are patients currently able to enroll in this ongoing study?

"Information from clinicaltrials.gov indicates that the ongoing trial is presently not accepting new participants. Initially shared on 5/1/2024 and most recently revised on 4/18/2024, this study does not require additional subjects currently. It's noteworthy that amidst numerous active trials, approximately 2606 are actively seeking eligible candidates for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy

2024. "A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06378398.

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