Clinical trial · Observational
Screening Tests in Detecting Colorectal Cancer
Colorectal Cancer Screening: Fecal Blood vs. DNA
NCT00025025CI-TRIAL-00022824completedClinicalTrials.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)
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for colorectal cancer. PURPOSE: Randomized screening trial to compare the effectiveness of fecal occult blood testing with that of DNA-based testing of stool and blood in identifying colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sample testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm I
- description
- Participants eat no red meat and take no nonsteroidal anti-inflammatory drugs (NSAIDs) and no vitamin C or multivitamins for 3 days prior to and during stool sample collection. Participants collect stool samples 3 different times and perform fecal occult blood (FOB) test smears from each stool. After each collection, participants ship the whole stool and FOB test smear to their participating center for blinded multitarget DNA-based assay panel (MTAP) testing. Within 2 months after stool sample collection, participants have their blood drawn for additional MTAP testing and undergo colonoscopy.
- interventionNames
- Other: sample testing
- label
- Arm II
- description
- Participants take no vitamin C or multivitamins for 3 days before and during stool sample collection. Participants collect stool samples and FOB test smears and samples are tested as in arm I. Within 2 months after stool sample collection, participants have their blood drawn for additional MTAP testing and undergo colonoscopy.
- interventionNames
- Other: sample testing
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Required Characteristics: 1. ≥ 65 and ≤ 80 years of age. 2. Females must be postmenopausal (absence of menstrual periods for at least one year; patients on regular hormone replacement therapy; surgical intervention). Contraindications: 1. FOBT screening ≤1 year prior to randomization. 2. Structural colorectal evaluation (i.e. colonoscopy, colon x-ray, or sigmoidoscopy) ≤10 years prior to randomization. 3. Overt rectal bleeding (hematochezia or melena) ≤1 month prior to randomization. 4. Prior colorectal resection for any reason. 5. Inability to stop therapeutic doses of NSAIDs (prophylactic doses of aspirin (≤325 mg) allowed \[121\] and Cox2 inhibitors (i.e. Celebrex, Vioxx) allowed.) 6. Coagulopathy or inablitity to discontinue anticoagulants (discontinuation must be superviesed by a physician). 7. Aerodigestive cancer ≤5 years prior to randomization. 8. Contraindications to colonoscopy (e.g., serious cardiopulmonary disease). 9. High-risk conditions for colorectal cancer (familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer syndrome, other hereditary cancer syndromes, prior colorectal cancer or adenoma, inflammatory bowel disease, and * 2 first-degree relatives with colorectal cancer). 10. Chemotherapy ≤ 3 months prior to registration.
References
Publications (0)
Data not yet available
No reference posted for this study.