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


Phase 3
40 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Enrique Quintero, MD

Investigator Role:

Study Director

Investigator Affiliation:

Fundación Canaria para la Investigación Biomédica Rafael Clavijo

Authority:

Spain: Spanish Agency of Medicines

Study ID:

COLONFAM

NCT ID:

NCT01075633

Start Date:

September 2008

Completion Date:

December 2012

Related Keywords:

  • Colorectal Cancer
  • FOBT
  • colonoscopy
  • familiar risk
  • colorectal cancer
  • advanced adenoma
  • Colorectal Neoplasms

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