Colorectal Neoplasms Clinical Trial
Official title:
PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III
After curative surgical resection, detection of metastatic lymph node remains the main
prognostic validated criteria on which is based the decision of adjuvant therapy. To date,
none of the molecular alterations, identified as potentially predictive factor, are used in
routine for therapeutic decision. The circulating markers, either in the form of free
circulating DNA or in the form of circulating tumoral cells seems important potential
candidates. To investigators knowledge, only one study estimated with several interesting
results the prognostic interest of a coupled detection of the free circulating mutant DNA
(gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain
however difficult to achieve because of the small number of patient included (n=58) and the
fact that this study included different stages. For colorectal cancer a Chinese team
presented a series of results suggesting that the presence of CTC during the postoperative
course is a factor significantly related to the risk of recurrence. In multivariate analysis
integrating the lymph node status and the vascular invasion, the presence of CTC appeared as
an independent factor for recurrence with a hazard ratio of 29.5.
The aim of the present study is to compare the prognostic value of two circulating tumoral
markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating
tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two
circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival
rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA
and circulating tumoral cells in localised colorectal cancer.
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