Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 12:40 AM
Study NCT ID:
NCT02965703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Evaluating Intermittent Dosing of Aspirin for Colorectal Cancer Chemoprevention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-01642 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| N01-CN-2012-00035 | None | None | View | |
| NCI2015-06-01 | OTHER | Northwestern University | View | |
| NWU2015-06-01 | OTHER | DCP | View | |
| N01CN00035 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |