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Nonsteroidal Anti-inflammatory Drug

Aspirin for Colorectal Cancer

Phase < 1
Waitlist Available
Led By Andrew T Chan, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than or equal to 18 years and less than 55 years or greater than or equal to 65 years at the time of enrollment
ECOG performance status ≤2 (Karnofsky ≥60%)
Must not have
Any adenoma that was not completely removed during previous colonoscopy
Participant must be able to swallow pills
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months

Summary

This trial is looking at whether or not low doses of aspirin can help to prevent colorectal cancer.

Who is the study for?
This trial is for adults who've had at least one adenoma removed via colonoscopy in the last 9 months, are aged 18-55 or over 65, and haven't taken aspirin recently. Excluded are those with certain diseases (like inflammatory bowel disease), prior gastrointestinal cancers, recent use of NSAIDs, or conditions affecting study compliance.
What is being tested?
The ASPIRED-XT study is testing low-dose Aspirin as a preventive treatment for colorectal cancer compared to a placebo. Participants will be randomly assigned to receive either Aspirin or an inactive substance to evaluate its effectiveness in reducing cancer risk.
What are the potential side effects?
Aspirin may cause side effects such as increased bleeding risk, digestive tract irritation including ulcers and stomach pain, allergic reactions in some individuals, and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am either between 18 and 55 years old or 65 years and older.
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I can take care of myself but might not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had an adenoma that was not fully removed in a past colonoscopy.
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I can swallow pills.
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I have a history of reactions to aspirin, bleeding disorders, stomach ulcers, or issues with colonoscopies.
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I have not had treatment for any cancer, including gastrointestinal, in the last 3 years.
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I have been diagnosed with inflammatory bowel, liver, or kidney disease, or a bleeding disorder.
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I have been diagnosed with FAP or Lynch Syndrome.
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I cannot or will not stop taking aspirin/NSAIDs or give samples during the study.
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I do not have any uncontrolled illnesses.
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I am currently taking blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Change of ISC marker gene expression
Secondary study objectives
ChIP-seq Analysis of Colonic Epithelium
Change in Microbiome
Change in Urinary PGE-M
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants will be randomly assigned to placebo group and receive a daily placebo capsule for the duration of the study up to 12 weeks.
Group II: Low Dose AspirinExperimental Treatment1 Intervention
Participants will be randomly assigned to aspirin group and receive a daily low dose aspirin (81 mg) for the duration of the study up to 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,812 Previous Clinical Trials
8,161,310 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,444 Previous Clinical Trials
4,331,037 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,790 Total Patients Enrolled

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05056896 — Phase < 1
Colorectal Cancer Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT05056896 — Phase < 1
Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056896 — Phase < 1
Colorectal Cancer Research Study Groups: Placebo, Low Dose Aspirin
~47 spots leftby Nov 2025
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