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Aspirin for Barrett's Esophagus

Phase 2

Waitlist Available

Led By Robert S Bresalier

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Known diagnosis of histologically-confirmed BE with or without dysplasia requiring radiofrequency ablation

ECOG performance status =< 2

Must not have

Recent invasive cancer diagnosis or treatment

Current or planned use of anticoagulant drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

This trial studies aspirin to prevent Barrett's esophagus from returning after it has been treated. Samples of tissue will be studied for a protein linked to developing Barrett's esophagus.

Who is the study for?

This trial is for people who've had Barrett's Esophagus treated with radiofrequency ablation. They must not have used aspirin or similar drugs recently, agree to use contraception, and have normal blood counts and organ function. Excluded are those on anticoagulants, certain other medications, recent cancer treatments (except non-melanoma skin cancer), uncontrolled illnesses, pregnant or breastfeeding women, and those with HIV.

What is being tested?

The study tests if aspirin can prevent the recurrence of Barrett's Esophagus after successful treatment. Participants will be randomly given either aspirin or a placebo while researchers monitor protein levels in tissue samples to assess effectiveness.

What are the potential side effects?

Potential side effects include digestive issues like stomach ulcers or bleeding (especially if there’s a history of peptic ulcer disease), allergic reactions to aspirin-like substances, increased risk of bleeding due to its blood-thinning properties, and possibly liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Barrett's esophagus diagnosed through a biopsy, needing radiofrequency ablation.

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I can take care of myself and do some of my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been recently diagnosed or treated for cancer.

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I am currently using or plan to use blood thinners.

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My kidneys are not working properly and it's not under control.

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I cannot stop taking NSAID or COX-2 inhibitors.

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I have had a peptic ulcer that caused bleeding in my upper GI.

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I do not have any uncontrolled illnesses.

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I have a narrowing in my esophagus.

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I have had recent stomach or upper GI surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in the Change of CDX2 mRNA Levels in Esophageal Mucosa Between Participants Taking Aspirin and Placebo at 12 Months (Location A)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location A)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location B)

+3 more

Secondary study objectives

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location A)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location B)

Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location C)

+19 more

Other study objectives

Differences in the Prostanoid Marker, Prostaglandin E2, and Prostaglandin Synthases