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

NCT01251666 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19797

Last updated 2012-09-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Colonoscopy

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

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Ligue contre le cancer, France

    collaborator OTHER

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Guy LAUNOY, MD-PhD · University Hospital, Caen

Study Design

Allocation
NA
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01251666 on ClinicalTrials.gov