Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
COLONFAM
1 other identifier
interventional
1,501
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Jan 2006
Typical duration for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2010
CompletedFirst Posted
Study publicly available on registry
February 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 8, 2014
January 1, 2014
5.9 years
February 24, 2010
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]
2 years
Secondary Outcomes (1)
Complications rate
2 years
Study Arms (2)
Fecal occult blood testing
EXPERIMENTALImmunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Colonoscopy
ACTIVE COMPARATORColonoscopy with sedation.
Interventions
Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Eligibility Criteria
You may qualify if:
- Men and women aged 40-75 years, first degree relatives of patients with non-syndromic CRC
You may not qualify if:
- Personal history of CRC, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enrique Quinterolead
Study Sites (1)
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, 38320, Spain
Related Publications (2)
Gimeno-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: 19307978RESULTQuintero 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: 25127679DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Enrique Quintero, MD
Fundación Canaria para la Investigación Biomédica Rafael Clavijo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
February 24, 2010
First Posted
February 25, 2010
Study Start
January 1, 2006
Primary Completion
December 1, 2011
Study Completion
June 1, 2013
Last Updated
January 8, 2014
Record last verified: 2014-01