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Nonsteroidal Anti-inflammatory Drug

Aspirin for Preventing Colorectal Cancer in Patients With Adenomas

Phase 2

Waitlist Available

Led By Qi Dai

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

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Diagnosis of colorectal adenoma of any grade

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial will test how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma.

Who is the study for?

This trial is for adults with colorectal adenoma who are in good health, with specific blood and organ function criteria met. They must not have had invasive cancer in the past 2 years (except non-melanoma skin cancer), no chronic kidney or liver diseases, and not be on certain medications like NSAIDs or anticoagulants. Pregnant or breastfeeding women are excluded.Check my eligibility

What is being tested?

The study is testing if aspirin can prevent colorectal cancer in patients with colorectal adenomas by inhibiting enzymes needed for tumor growth. It involves taking aspirin versus a placebo, along with biospecimen collection, questionnaires, and rectal biopsies to assess effectiveness.See study design

What are the potential side effects?

Aspirin may cause side effects such as gastrointestinal issues like stomach pain and bleeding, allergic reactions, anemia due to potential bleeding risks, and possibly increased bruising or bleeding if there's interaction with other drugs.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly self-sufficient and can carry out daily activities.

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I have been diagnosed with a type of colon polyp called adenoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

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

Treatment Details

Study Objectives

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

Primary outcome measures

Ratio of cell proliferation to apoptosis biomarkers (Ki67 index and BAX index)

Secondary outcome measures

Fecal occult blood test (measures of adverse events) as measured by stool samples

Ratio of cell proliferation (Ki-67)/apoptosis (TdT-mediated dUTP nick end labeling [TUNEL]) in rectal biopsies

Ratio of cell proliferation (Ki-67)/necroptosis (MLKL) in rectal biopsies

Other outcome measures

Escherichia coli

BCL2-Associated X Protein (BAX) in rectal biopsies

COX-2 in rectal biopsies

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm II (aspirin, placebo)Experimental Treatment5 Interventions

Patients receive aspirin PO daily at weeks 1-3 and 7-9 and placebo PO daily at weeks 4-6 and 10-12 in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Group II: Arm I (aspirin)Experimental Treatment4 Interventions

Patients receive aspirin PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Group III: Arm III (placebo)Placebo Group4 Interventions

Patients receive placebo PO daily for 12 weeks in the absence of unacceptable toxicity. Patients also undergo collection of blood, urine, stool, rectal swab samples, and rectal biopsies throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aspirin

2014

Completed Phase 4

~55580

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,658 Previous Clinical Trials

40,924,560 Total Patients Enrolled

5 Trials studying Colorectal Adenomas

6,059 Patients Enrolled for Colorectal Adenomas

Qi DaiPrincipal InvestigatorNorthwestern University

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT02965703 — Phase 2

Colorectal Adenomas Research Study Groups: Arm I (aspirin), Arm II (aspirin, placebo), Arm III (placebo)

Colorectal Adenomas Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT02965703 — Phase 2

Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02965703 — Phase 2

Frequently Asked Questions

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

Does this experiment offer opportunities for patient participation?

"This medical study is not currently accepting new applicants. It was first posted on the 16th of January 2018 and has been updated on September 20th 2022. Alternative studies may be available, with 95 trials recruiting patients for colorectal adenomas and 168 clinical tests seeking participants for aspirin-based treatments."

Answered by AI

To what medical issues is Aspirin commonly prescribed?

"Percutaneous coronary intervention (PCI), dental operations, and cases of inflammation may all be relieved by taking Aspirin."

Answered by AI

Is this research a pioneering endeavor?

"Currently, there are 168 active studies in regards to Aspirin being conducted across 57 countries and 1398 different cities. This research began with Abbott's Phase 4 clinical trial back in 2005 which required 15480 participants for completion. Since then, 1213 trials have been successfully carried out."

Answered by AI

What potential risks and warnings should be taken into account when using Aspirin?

"Aspirin has been evaluated for safety in a Phase 2 clinical trial, so it was given an assessment of 2. At this stage there is some evidence to suggest its safety but no research that testifies to its efficacy."

Answered by AI

How many individuals have been recruited for this research endeavor?

"This clinical trial has concluded its recruitment, as the last update was on September 20th 2022. However, there are currently 95 trials recruiting for colorectal adenomas and 168 studies searching for participants with aspirin-related concerns."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

2018. "Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02965703.

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