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Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening

NCT ID: NCT01251666

Last Updated: 2012-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

19797 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-08-31

Brief Summary

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Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.

Detailed Description

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Conditions

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Colorectal Cancer

Keywords

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Colorectal cancer Screening Average-risk population faecal occult blood tests

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Magstream + Oc Sensor + Hemoccult II

Each patient will perform all three tests:

* Magstream: 2 samples (each on a different stool)
* OC Sensor: 2 samples (each on a different stool)
* Hemoccult II: 6 samples (2 samples per stool, on 3 different stools)

Each test will be considered as positive if at least one sample is positive (cutoff for Magstream 55 ng/ml and for OC Sensor 150 ng/ml).

Screening will be considered as positive if at least one of the three tests is positive, leading to a colonoscopy

Group Type OTHER

Colonoscopy

Intervention Type OTHER

Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)

Interventions

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Colonoscopy

Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 50 to 74 years
* Informed consent signed

Exclusion Criteria

* Recent digestive symptoms
* Complete colonoscopy less than 5 years ago
* Personal history of colorectal cancer or colorectal adenoma or colonic disease requiring regular colonoscopy surveillance
* Familial history of colorectal cancer in a first degree next of kin before 65 years, or two cases in first degree next of kin.
* Severe extra-intestinal disease
* Screening ill-timed (ex. depression)
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

Ligue contre le cancer, France

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy LAUNOY, MD-PhD

Role: STUDY_DIRECTOR

University Hospital, Caen

Locations

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ADECA

Moulins, , France

Site Status

Adoc18 - Irsa

Saint-Doulchard, , France

Site Status

Countries

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France

References

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Raginel T, Puvinel J, Ferrand O, Bouvier V, Levillain R, Ruiz A, Lantieri O, Launoy G, Guittet L. A population-based comparison of immunochemical fecal occult blood tests for colorectal cancer screening. Gastroenterology. 2013 May;144(5):918-25. doi: 10.1053/j.gastro.2013.01.042. Epub 2013 Feb 1.

Reference Type DERIVED
PMID: 23376426 (View on PubMed)

Other Identifiers

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2008-A01463-52

Identifier Type: -

Identifier Source: org_study_id