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

Colorectal Cancer Clinical Trial

— COLONFAM  

Official title:

Colorectal Cancer Screening in Familiar-Risk Population: a Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075633
• Other study ID #: COLONFAM
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2010
• Last updated: January 7, 2014
• Start date: January 2006
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Fundación Canaria Rafael Clavijo para la Investigación Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1501
• Est. completion date: June 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Colonoscopy with sedation
Colonoscopy with sedation

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Enrique Quintero

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Gimeno-García AZ, Quintero E, Nicolás-Pérez D, Hernández-Guerra M, Parra-Blanco A, Jiménez-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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advanced colorectal neoplasm detection rate [Time Frame: 2 years] [Designated as safety issue: No]		2 years	No
Secondary	Complications rate		2 years	No