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Nonsteroidal Anti-inflammatory Drug

Aspirin for Colorectal Cancer Prevention (ASPIRED Trial)

N/A

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

Not currently taking aspirin (any dose) within the last 6 months

Age 18-80 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-12 weeks

Awards & highlights

ASPIRED Trial Summary

This trial is testing whether aspirin can help prevent colorectal cancer.

Who is the study for?

This trial is for adults aged 18-80 who've had at least one adenoma removed via colonoscopy in the last 9 months, are not currently on aspirin, and can sign consent. Excluded are those on anticoagulants or NSAIDs regularly, with certain genetic syndromes like FAP or Lynch Syndrome, uncontrolled illnesses, pregnant/breastfeeding women, and those unable to swallow pills.Check my eligibility

What is being tested?

The study is looking into whether taking aspirin can help prevent colorectal cancer in people who have had adenomas removed. Participants will either receive aspirin or a placebo (a pill without any medicine) to compare the effects.See study design

What are the potential side effects?

Aspirin may cause side effects such as increased risk of bleeding, allergic reactions for those sensitive to it, digestive issues like ulcers or gastrointestinal bleeds especially if there's a history of intolerance.

ASPIRED Trial Eligibility Criteria

Inclusion Criteria

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

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I haven't taken aspirin in the last 6 months.

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I am between 18 and 80 years old.

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I had a colonoscopy at MGH within the last 9 months and had at least one adenoma removed.

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I can take care of myself but might not be able to do active work.

ASPIRED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Urinary Prostaglandin Metabolites (PGE-M)

Secondary outcome measures

Chromatin Binding

Expression of Wnt-associated Signaling Genes (CTNNB1, AXIN2 and MYC)

Plasma Macrophage Inhibitory Cytokine-1 (MIC-1), an Inflammatory Biomarker

+1 more

ASPIRED Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Low Dose AspirinActive Control1 Intervention

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (81 mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Group II: Standard Dose AspirinActive Control1 Intervention

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose (325mg/d), once daily, until the final visit. Duration not to exceed 12 weeks.

Group III: Placebo (For Aspirin)Placebo Group1 Intervention

The first dose of the study medication will be given to patients after the initial flexible sigmoidoscopy (start of randomization). Participants will be expected to take one capsule orally at the blinded dose, once daily, until the final visit. Duration not to exceed 12 weeks.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,309 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,929 Previous Clinical Trials

13,198,125 Total Patients Enrolled

Andrew T Chan, MD, MPHPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

160 Total Patients Enrolled

Media Library

Aspirin (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT02394769 — N/A

Colorectal Cancer Research Study Groups: Low Dose Aspirin, Placebo (For Aspirin), Standard Dose Aspirin

Colorectal Cancer Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT02394769 — N/A

Aspirin (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02394769 — N/A

Frequently Asked Questions

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

Is there an opportunity for me to participate in this experiment?

"Admission to this clinical trial necessitates that individuals have colorectal cancer, and range in age from 18 to 80 years old. As of now, the research team is hoping to recruit 180 participants."

Answered by AI

Is the population of this medical experiment restricted to people below thirty years old?

"In order to take part in this research trial, individuals must be of a minimum age 18 and not exceed 80 years old."

Answered by AI

What is the current capacity for enrollees in this clinical trial?

"No, this particular medical trial is no longer enrolling patients. Originally posted on July 6th 2015 and last updated August 31st 2022, the experiment has since concluded its recruitment process. However, there are 1064 other clinical trials for colorectal cancer that remain open to participants as well as 167 studies looking into Standard Dose Aspirin."

Answered by AI

Is this analysis still accepting participants?

"The clinicaltrials.gov database reveals that this trial, initially posted on July 6th 2015 and last edited August 31st 2022 is not recruiting any more candidates. Nevertheless, there are 1,231 other trials at the moment actively enrolling patients."

Answered by AI

Is this endeavor pioneering its field?

"Currently, there are 167 ongoing investigations for Standard Dose Aspirin scattered throughout 57 different nations and 1398 cities. The first clinical trial was sponsored by Abbott in 2005 and comprised of 15480 participants. Subsequently, it completed its Phase 4 drug approval with a total of 511 trials concluded since then."

Answered by AI

To what maladies is Standard Dose Aspirin typically prescribed?

"Generally speaking, percutaneous coronary intervention (pci) is best treated with a Standard Dose Aspirin. That said, this medication can also ameliorate the pain associated with dental procedures, inflammation and neck aches."

Answered by AI

Recent research and studies

TrialsJournal

Aspirin Intervention for the Reduction of Colorectal Cancer Risk (ASPIRED): A Study Protocol for a Randomized Controlled Trial

Drew, David A., Samantha M. Chin, Katherine K. Gilpin, Melanie Parziale, Emily Pond, Madeline M. Schuck, Kathleen Stewart, et al.. 2017. “Aspirin Intervention for the Reduction of Colorectal Cancer Risk (ASPIRED): A Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-016-1744-z.

Cancer Prevention ResearchJournal

Effect of Low-dose and Standard-dose Aspirin on PGE2 Biosynthesis Among Individuals with Colorectal Adenomas: A Randomized Clinical Trial

Drew, David A., Madeline M. Schuck, Marina V. Magicheva-Gupta, Kathleen O. Stewart, Katherine K. Gilpin, Patrick Miller, Melanie P. Parziale, et al.. 2020. “Effect of Low-dose and Standard-dose Aspirin on PGE2 Biosynthesis Among Individuals with Colorectal Adenomas: A Randomized Clinical Trial”. Cancer Prevention Research. American Association for Cancer Research (AACR). doi:10.1158/1940-6207.capr-20-0216.

clinicaltrials.govStudy

ASPirin Intervention for the REDuction of Colorectal Cancer Risk

Andrew T. Chan, MD, MPH 2015. "ASPirin Intervention for the REDuction of Colorectal Cancer Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02394769.

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