Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma (NCT02965703) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma
United States81 participantsStarted 2018-01-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of colorectal adenoma of any grade
* Age \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of aspirin in participants \< 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Leukocytes \>= 3,000/microliter
* Absolute neutrophil count \>= 1,500/microliter
* Platelets \>= 150,000/microliter
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x institutional ULN
* Creatinine =\< 1.5 x institutional ULN
* Blood hemoglobin \>= 12.0 g/dL
* Alkaline phosphatase =\< 1.5 x institutional ULN
* Blood urea nitrogen (BUN) =\< 40 mg/dL
* Estimated glomerular filtration rate (eGFR) \>= 45 mL/min
* Negative fecal occult blood test
* The effects of aspirin on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study phy…
What they're measuring
1
Ratio of Cell Proliferation to Apoptosis Biomarkers (Ki67 Index and BAX Index)
Timeframe: Baseline to end of intervention up to 12 weeks