Phase 2
Completed N=79
Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
Colorectal Cancer · Precancerous Condition
Source: ClinicalTrials.gov NCT00468910 ↗
Enrolled (actual)
79
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months. — 40.72; 37.54; 43.45; 37.52 micron^-1 — p=0.11
Summary
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months. |
40.72; 37.54; 43.45; 37.52 | 0.11 |
| PRIMARY Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Fractal Dimension or FRAC) From Baseline to 3 Months. |
142.41; 23.28; -407.78; 650.97 | 0.17 |
| SECONDARY Colonic Epithelial Apoptosis as Measured by Immunohistochemical Detection of Cleaved Caspase 3 |
4.56; 5.24; 4.26; 7.26 | — |
| SECONDARY Changes in Colonic Cell Proliferation as Measured by Immunohistochemical Detection of Ki67 |
38.07; 40.45; 43.60; 37.74 | — |
| SECONDARY Rectal Prostaglandin Levels as Measured by ELISA |
305.93; 654.64; 211.97; 209.02 | — |
Eligibility Criteria
Criteria:
- No active or metastatic cancer within the past 6 months
- Scheduled to undergo colonoscopy for colonic neoplasia surveillance
- Hemoglobin >= 12.0 g/dL
- Platelet count >= 120,000/mm^3
- AST or ALT = = 45 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No coagulopathy
- No anemia
- No history of peptic ulcer disease or gastrointestinal hemorrhage
- No history of cerebrovascular accident
- No uncontrolled hypertension
- No history of intolerance or allergy to aspirin or to NSAIDs
- No liver disease as manifested by signs or symptoms of cirrhosis
- No endoscopic or radiographic evidence of portal hypertension
- No active colitis by endoscopy
- No history of inflammatory bowel disease
- No requirement for aspirin as medical therapy (i.e., post-myocardial infarction or transient ischemic attack)
- No untreated helicobacter pylori infection
- History of significant colonic neoplasia, defined as 1 of the following:
- Adenoma within the past 6 years
- Colorectal cancer within the past 6 years
- Known adenoma on present exam
- Histologically confirmed polyps seen on imaging
- INR =< 1.5
- At least 6 months since prior cancer treatment
- No other concurrent acetylsalicylic acid (aspirin)-containing products or non-steroidal anti-inflammatory drugs (NSAIDs)
- No concurrent systemic corticosteroids
- No other concurrent anticoagulants or antiplatelet agents
- No concurrent investigational drugs
Data sourced from ClinicalTrials.gov (NCT00468910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.