Aspirin for Colorectal Adenomas

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Colorectal Adenomas+1 More
Aspirin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Colorectal Adenomas

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 9 months

Week 12
Escherichia coli
BCL2-Associated X Protein (BAX) in rectal biopsies
COX-2 in rectal biopsies
Joint index of BAX with TRPM7 expression in rectal biopsies
Joint index of COX-2 with Transient Receptor Potential Cation Channel Subfamily M Member 7 (TRPM7) expression in rectal biopsies
Methylation in CDKN2A (cell cycle regulation), MGMT (deoxyribonucleic acid [DNA] repair), DAPK1 (apoptosis), CDH1 (cell invasion), WNT16 (Wnt pathway), and RASSF1 (RAS signaling) assessed by pyrosequencing method
Transient Receptor Potential Cation Channel Subfamily M Member 7 (TRPM7) in rectal biospies
Up to 12 weeks
Fecal occult blood test (measures of adverse events) as measured by stool samples
Fecal occult blood test assessed in stool samples
Ratio of cell proliferation (Ki-67)/apoptosis (TdT-mediated dUTP nick end labeling [TUNEL]) assessed in rectal biopsies
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) assessed in rectal biopsies
Ratio of cell proliferation (Ki-67)/necroptosis (MLKL) in rectal biopsies
Up to 3 months
Ratio of cell proliferation to apoptosis biomarkers (Ki67 index and BAX index)
Up to 9 months
Abundance of Escherichia coli and fusobacterium assessed by rectal swabs
Dietary intake of calcium measured by the Food Frequency Questionnaire

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Aspirin
4%Bleeding
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02053909) in the Aspirin ARM group. Side effects include: Bleeding with 4%.

Trial Design

3 Treatment Groups

Arm II (aspirin, placebo)
1 of 3
Arm I (aspirin)
1 of 3
Arm III (placebo)
1 of 3

Experimental Treatment

Non-Treatment Group

81 Total Participants · 3 Treatment Groups

Primary Treatment: Aspirin · Has Placebo Group · Phase 2

Arm II (aspirin, placebo)Experimental Group · 6 Interventions: Aspirin, Placebo Administration, Laboratory Biomarker Analysis, Biospecimen Collection, Rectal Biopsy, Questionnaire Administration · Intervention Types: Drug, Other, Other, Procedure, Procedure, Other
Arm I (aspirin)Experimental Group · 5 Interventions: Aspirin, Laboratory Biomarker Analysis, Biospecimen Collection, Rectal Biopsy, Questionnaire Administration · Intervention Types: Drug, Other, Procedure, Procedure, Other
Arm III (placebo)PlaceboComparator Group · 5 Interventions: Placebo Administration, Laboratory Biomarker Analysis, Biospecimen Collection, Rectal Biopsy, Questionnaire Administration · Intervention Types: Other, Other, Procedure, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylsalicylic acid
FDA approved
Biospecimen Collection
2004
Completed Phase 1
~670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 9 months

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,995 Previous Clinical Trials
41,299,855 Total Patients Enrolled
5 Trials studying Colorectal Adenomas
6,059 Patients Enrolled for Colorectal Adenomas
Qi DaiPrincipal InvestigatorNorthwestern University

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of colorectal adenoma of any grade.
The study is evaluating whether a low dose of aspirin may help prevent migraine headaches in adults.
You have leukocytes greater than 3,000/microliter.
You have a creatinine level of at least 1.5 times the institutional ULN.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.