Clinical trial · Interventional
Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia
NCT00468910CI-TRIAL-00027913completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetylsalicylic acid | Drug | Aspirin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral acetylsalicylic acid (aspirin) once daily.
- interventionNames
- Drug: acetylsalicylic acid
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo once daily.
- interventionNames
- Drug: placebo
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Change of a Spectral Biomarker for Colonic Carcinogenesis (Called Spectral Slope or SPEC) From Baseline to 3 Months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 75 Years
Show eligibility criteria text
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 =\< 1.5 times upper limit of normal (ULN) * Alkaline phosphatase =\< 1.5 times ULN * Bilirubin =\< 1.5 times ULN * BUN =\< 40 mg/dL * Glomerular filtration rate \>= 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
References
Publications (1)
- DERIVEDRoy HK, Turzhitsky V, Wali R, Radosevich AJ, Jovanovic B, Della'Zanna G, Umar A, Rubin DT, Goldberg MJ, Bianchi L, De La Cruz M, Bogojevic A, Helenowski IB, Rodriguez L, Chatterton R, Skripkauskas S, Page K, Weber CR, Huang X, Richmond E, Bergan RC, Backman V. Spectral biomarkers for chemoprevention of colonic neoplasia: a placebo-controlled double-blinded trial with aspirin. Gut. 2017 Feb;66(2):285-292. doi: 10.1136/gutjnl-2015-309996. Epub 2015 Oct 26. PMID 26503631