Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
Prospective cohort study of patients treated with systemic chemotherapy for unresectable
metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological
evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free
mutant DNA, CTC represent an alternative approach. A previous study on usefulness of the
serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with
unresectable metastasis of colorectal cancer has been published (J Clin Oncol
2008;26:3681-6). The present study is designed to validate the previous data. The secondary
purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy.
Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy
and biotherapy validate in this clinical situation by the French National Cancer Institute
(INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every
3 months. Blood samples for CEA and CA 19-9 levels will be performed every courses of
chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC
will be performed at day 1 and 42 of chemotherapy.
Interventional
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Prediction of tumor progression
sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST)
3 months
No
Pierre MICHEL, Pr
Principal Investigator
UH Rouen
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2009/170/HP
NCT01212510
October 2010
October 2015
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