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Validation of an Alternative Biological Test to Increase the Detection Sensitivity of a Colon Tumour

NCT01270360 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 502

Last updated 2015-06-15

No results posted yet for this study

Summary

Screening campaigns for colorectal cancer (CRC) involve two steps: the detection of occult blood in stools using a Hemoccult GAIAC test (FOBT) on three consecutive stool samples, followed by colonoscopy if the result is positive. The information quality of the Hemoccult test, however, is poor: in the asymptomatic 50 to 74 year-old population, the detection sensitivity of polyps more than 1 cm in diameter is of the order of 10 to 30% and is 35 to 50% for detecting colorectal cancers; specificity is 94 to 98% that of a complete colonoscopy. The I-FOBTs based on immunological detection and quantification of occult blood in stools are currently being evaluated; based on the threshold it can be more sensitive than FOBT, but enhances useless colonoscopies. Alternatively, with highest threshold of blood in stools, it may become highly specific and miss less advanced polyps. Faecal molecular tests based on the detection of human DNA anomalies (point gene mutations, methylation disorders of CG islets) appear to be more sensitive than the detection of occult blood in stools with no loss of specificity, but they are very expensive, thereby limiting their generalisation to the scale of population screening. A formal methylated DNA test has been validated in stools as well as in blood in a cohort of symptomatic individuals having undergone colonoscopy. The aim of the present study is to validate this test by taking advantage of the biotechnical expertise from renowned academic research teams and mass screening organisation.

Conditions

Interventions

DEVICE

COLOHYBRITEST OR VALIHYBRITEST

Detection of human colon or rectal tumours by using a simplified molecular test based on either a combination of methylated DNA or protein marker(s) alone or considered together in biological fluids like blood, urine and stools

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Iradj Sobhani, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • France

Study Locations

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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 NCT01270360 on ClinicalTrials.gov