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Colorectal Cancer Screening in Familiar-Risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy (COLONFAM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Enrique Quintero, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier:
NCT01075633
First received: February 24, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Procedure: Immunochemical fecal occult blood test And colonoscopy if test is positive
Procedure: Colonoscopy with sedation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Colorectal Cancer Screening in Familiar-Risk Population: a Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Resource links provided by NLM:


Further study details as provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:

Primary Outcome Measures:
  • Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No] [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1501
Study Start Date: January 2006
Study Completion Date: June 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal occult blood testing
Immunochemical fecal occult blood test Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Procedure: Immunochemical fecal occult blood test And colonoscopy if test is positive
Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
Active Comparator: Colonoscopy
Colonoscopy with sedation.
Procedure: Colonoscopy with sedation
Colonoscopy with sedation

Detailed Description:

This is an observational, controlled, randomized phase III study to evaluate the effectiveness of the iFOBT for detecting advanced neoplasia (polyps > 1cm in size, high grade dysplasia or with villous component, or CRC) in first degree relatives of patients with CRC.

Index cases will be interviewed to obtain the family tree and their first-degree relatives will be contacted to invite them to participate in the study. Index-cases, will be randomized into one of the following two groups in order that their relatives receive the same screening strategy: A) colonoscopy; or B) annual iFOBT test (OC-Sensor®, cut off ≥50 ng/ml) and colonoscopy if positive. To determine the sensitivity and specificity of the iFOBT strategy, individuals randomized to group B will be invited to undergo a complete colonoscopy following two years follow-up. In addition, epidemiological data, personal history of disease, family history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis will be recorded.

To test the hypothesis of equivalence between the iFOBT test and colonoscopy for detecting advanced colorectal neoplasm, it was considered a probability of participation, detection capability and prevalence of advanced adenomas for iFOBT of 0.750, 0.565 and 0.077, respectively, being the product of them 0.033. In the case of colonoscopy, the likelihood of participation, detection capability and prevalence of advanced adenomas in this population at risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. Accordingly, for a Type I error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities of the two tests of 0.03 the number of subjects to be included per arm is 744

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075633

Locations
Spain
Hospital Universitario de Canarias
Tenerife, Spain, 38320
Sponsors and Collaborators
Enrique Quintero
Investigators
Study Director: Enrique Quintero, MD Fundación Canaria para la Investigación Biomédica Rafael Clavijo
  More Information

Publications:
Responsible Party: Enrique Quintero, PhD, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier: NCT01075633     History of Changes
Other Study ID Numbers: COLONFAM
Study First Received: February 24, 2010
Last Updated: January 7, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:
FOBT
colonoscopy
familiar risk
colorectal cancer
advanced adenoma

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014