Trial Information

Validation of a Non Invasive methylateDNA Test for te Diagnosis of Colorectal Tumour in Asymptomatic Individuals

This study search to validate a test by taking advantage of the biotechnical expertise from
renowned academic research teams and mass screening organisation.

In order to reduce the cost of the present study the investigators will select in this
preliminary study only those individuals who have a FOBT. However, we'll measure the blood
level by using a I-FOBT test to quantify Haemoglobin concentration in stools. Furthermore,
we'll use stool DNA to characterize microbiota according to the colonoscopy findings. In
addition, the investigators believe it is important to include in the project, the creation
of biological blood and urine collections from individuals having undergone both faecal
tests and a reference colonoscopy. In the future, these collections will be made available
to the national or international scientific community (after consent by the principal
investigators) to validate any other molecular and/or protein marker including proteomic
analysis by using MSS. The investigators will perform methylated DNA test in either stools
or blood and will compare results to those of I-FOBT and colonoscopy.

A simplified molecular test based on a combination of the search for methylation anomalies
(one PCR and/or dedicated microarray) a limited number of gene targets involved in
colorectal carcinogenesis is available. The investigators will collect stools, urine, and
blood in a period of 15 to 2 days prior to colonoscopy. The colonoscopy is performed in
50-74 years old asymptomatic individuals who have presented with a positive FOBT test under
mass screening organisation. A final point will be performed 5 years after entry in the
trial for all 1000 individuals in order to check occurrence (alternative absence) of any
disease during this period and the type of the disease for those individuals who will be
shown with normal colonoscopy and to verify evolution of those who will presented with a
colon or rectal tumor. Likelihood value of marker in diseases occurring during the survey
period will be calculated and prognostic values estimated in those with colon or rectal
cancer.