Clinical trial · Interventional
Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
Colonoscopy Screening Trial
NCT00102011CI-TRIAL-0010498300-046completedPhase 3ClinicalTrials.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, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer. PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| annual screening | Procedure | — | UNRESOLVED |
| fecal occult blood test | Procedure | — | UNRESOLVED |
| screening colonoscopy | Procedure | — | UNRESOLVED |
| standard follow-up care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Study I- Arm I
- description
- Participants undergo baseline screening colonoscopy
- interventionNames
- Procedure: screening colonoscopy
- type
- OTHER
- label
- Study I- Arm II
- description
- Participants receive standard care
- interventionNames
- Procedure: fecal occult blood test
- Procedure: standard follow-up care
- type
- EXPERIMENTAL
- label
- Study II- Arm I
- description
- Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Healthy participants at average risk for developing colorectal cancer * No history of colorectal cancer * No history of familial adenomatous polyposis * More than 5 years since prior flexible sigmoidoscopy * No prior colonoscopy PATIENT CHARACTERISTICS: Age * 50 to 69 (40 to 69 at the Louisiana State University participating site) Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No myocardial infarction within the past year * No congestive heart failure Pulmonary * No chronic obstructive pulmonary disease Gastrointestinal * No history of ulcerative colitis * No history of Crohn's disease * No history of inflammatory bowel disease Other * No serious comorbid condition * No consumption of red meat within 3 days prior to and during FOBT (feasibility study II, arm II only) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No concurrent chemotherapy other than for nonmelanoma skin cancer Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No vitamin C consumption \> 250 mg within 3 days prior to and during fecal occult blood testing (FOBT) (feasibility study II arm II only) * No nonsteroidal anti-inflammatory drugs within 7 days prior to and during FOBT (feasibility study II, arm II only) * No concurrent anticoagulants * No concurrent anticancer therapy except for treatment of nonmelanoma skin cancer
References
Publications (3)
- BACKGROUNDShaukat A, Church TR, Shanley R, Kauff ND, O'Brien MJ, Mills GM, Jordan PA, Allen JA, Kim A, Feld AD, Zauber AG, Winawer SJ. Development and validation of a clinical score for predicting risk of adenoma at screening colonoscopy. Cancer Epidemiol Biomarkers Prev. 2015 Jun;24(6):913-20. doi: 10.1158/1055-9965.EPI-14-1321. Epub 2015 Mar 23. PMID 25800242
- BACKGROUNDMendelsohn RB, Winawer SJ, Jammula A, Mills G, Jordan P, O'Brien MJ, Close GM, Dorfman M, Church TR, Mandelson MT, Allen J, Feld A, Kauff ND, Morgan GA, Kumar JMR, Serrano V, Bayuga-Miller S, Fischer SE, Kuk D, Zauber AG. Adenoma Prevalence in Blacks and Whites Having Equal Adherence To Screening Colonoscopy: The National Colonoscopy Study. Clin Gastroenterol Hepatol. 2017 Sep;15(9):1469-1470. doi: 10.1016/j.cgh.2017.04.014. Epub 2017 Apr 15. No abstract available. PMID 28419856
- DERIVEDZauber AG, Winawer SJ, O'Brien MJ, Mills GM, Allen JI, Feld AD, Jordan PA, Fleisher M, Orlow I, Meester RGS, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, Mandelson M, Shaukat A, Mendelsohn RB, Hahn AI, Lobaugh SM, Soto Palmer B, Serrano V, Kumar JR, Fischer SE, Chen JC, Bayuga-Miller S, Kuk D, O'Connell K, Church TR. Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test. Gastroenterology. 2023 Jul;165(1):252-266. doi: 10.1053/j.gastro.2023.03.206. Epub 2023 Mar 21. PMID 36948424