Aspirin in Preventing Colorectal Cancer in Patients With Colorectal

Status Active, not recruiting

Clinical Trial Summary

This phase IIa trial studies how well aspirin works in preventing colorectal cancer in patients with colorectal adenoma. Aspirin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To test for the equivalency of the two aspirin schedules. SECONDARY OBJECTIVES: I. To evaluate the effects of aspirin treatments on: Ia. The ratio of cell proliferation (Ki-67)/apoptosis (TUNEL) in rectal biopsies; Ib. The ratio of cell proliferation (Ki-67)/necroptosis (pMLKL) in rectal biopsies; Ic. Fecal occult blood test (measures of adverse events) as measured by stool samples. EXPLORATORY OBJECTIVES: I. To evaluate the effects of aspirin treatments on: Ia. Cyclooxygenase-2 (COX-2) in rectal biopsies; Ib. Bcl-2-like protein 4 (BAX) in rectal biopsies; Ic. Transient receptor potential cation channel subfamily M member (7TRPM7) in rectal biopsies; Id. Joint index of COX-2 with TRPM7 expression in rectal biopsies; Ie. Joint index of TRPM7 with BAX in rectal biopsies; If. Methylation assays using the MethylationEPIC BeadChip to identify methylation biomarkers in genes (i.e. CDKN2A [cell cycle regulation], MGMT [deoxyribonucleic acid (DNA) repair], DAPK1 [apoptosis], CDH1 [cell invasion], WNT16 [Wnt pathway] and RASSF1 [RAS signaling]) involved in colorectal carcinogenesis, and other epigenome-wide methylation biomarkers as measured in rectal biopsies; Ig. Metagenomics analysis to measure abundance of Escherichia coli (E. coli) and Fusobacterium and other microbiota in rectal swabs. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive aspirin orally (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. ARM II: 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. ARM III: 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. After completion of study, patients are followed up at 1 month. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02965703
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 16, 2018
Completion date	July 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04192565` - A Prospective Investigation of the ColubrisMX ELS System	N/A
Recruiting	`NCT04516785` - Reducing Colonoscopies in Patients Without Significant Bowel Disease
Recruiting	`NCT05381792` - Serial Gut Microbiome and Bacterial Gene Markers Changes After Endoscopic Resection of Colorectal Advanced Neoplasia
Withdrawn	`NCT05606081` - Predicting Risk for Post-polypectomy Colorectal Cancer	N/A
Recruiting	`NCT05576506` - Application of Hyperspectral Imaging Analysis Technology in the Diagnosis of Colorectal Cancer Based on Colonoscopic Biopsy
Active, not recruiting	`NCT03796884` - Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer	Phase 2
Completed	`NCT05508503` - A Study on a Blood-based Dual-target Test for CRC Detection
Recruiting	`NCT02935049` - Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique	N/A
Completed	`NCT05477836` - Feasibility and Safety of MiWEndo-assisted Colonoscopy	N/A
Active, not recruiting	`NCT05754229` - Accuracy of Real Time Characterization in Artificial Intelligence-assisted Colonoscopy	N/A
Active, not recruiting	`NCT05740137` - Adenoma Detection Rate in Artificial Intelligence-assisted Colonoscopy	N/A
Completed	`NCT03234725` - Analysis of New Endoscopic Features and Variable Stiffness in Colonoscopy: Prospective Randomised Trial
Completed	`NCT05913453` - Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
Recruiting	`NCT05261932` - Research on Endoscopic Precision Biopsy.
Completed	`NCT02521727` - To Investigate Risk of Colorectal Neoplasms in First-degree Relatives of Patients With Non-advanced Adenomas
Completed	`NCT02226185` - Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence	Phase 2/Phase 3
Completed	`NCT00298545` - Effect of Vitamin D and Calcium on Genes in the Colon	Phase 1
Completed	`NCT03268655` - Ginger and Gut Microbiome (GINGER)	N/A
Active, not recruiting	`NCT04952129` - Optimal Selenium for Bowel Polyps (OSCAR)	Phase 1
Recruiting	`NCT04444908` - Development and Validation of an Artificial Intelligence-assisted Strategy Selection System for Colonoscopy Cleaning

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms