Clinical trial · Interventional
Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Colorectal Cancer Screening in Familiar-Risk Population: a Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
NCT01075633CI-TRIAL-00013350COLONFAMcompletedPhase 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)
This study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal occult blood test (iFOBT) and colonoscopy when positive for colorectal cancer (CRC) screening in familiar-risk population and; 2) to determine the complications associated with both strategies.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy with sedation | Procedure | — | UNRESOLVED |
| Immunochemical fecal occult blood test And colonoscopy if test is positive | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fecal occult blood testing
- description
- Immunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
- interventionNames
- Procedure: Immunochemical fecal occult blood test And colonoscopy if test is positive
- type
- ACTIVE_COMPARATOR
- label
- Colonoscopy
- description
- Colonoscopy with sedation.
- interventionNames
- Procedure: Colonoscopy with sedation
Primary outcomes (1)
- measure
- Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women aged 40-75 years, first degree relatives of patients with non-syndromic CRC Exclusion Criteria: * Personal history of CRC, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
References
Publications (2)
- RESULTGimeno-Garcia AZ, Quintero E, Nicolas-Perez D, Hernandez-Guerra M, Parra-Blanco A, Jimenez-Sosa A. Screening for familial colorectal cancer with a sensitive immunochemical fecal occult blood test: a pilot study. Eur J Gastroenterol Hepatol. 2009 Sep;21(9):1062-7. doi: 10.1097/MEG.0b013e3283293797. PMID 19307978
- DERIVEDQuintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13. PMID 25127679