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Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

18 Years
95 Years
Open (Enrolling)
Metastatic Colorectal Cancer

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Trial Information

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.

Inclusion Criteria:

- Patient has Stage IV colorectal adenocarcinoma histologically proved

- Patient has at least one measurable lesion

- Patient has performance status 0-2 on the WHO performance scale

- Patient is male or female, and > 18 years of age

- Patient has agree to participate by giving written informed consent

Exclusion Criteria:

- Patient has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.

Type of Study:


Study Design:

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Prediction of tumor progression

Outcome Description:

sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST)

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Pierre MICHEL, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

UH Rouen


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2010

Completion Date:

October 2015

Related Keywords:

  • Metastatic Colorectal Cancer
  • metastatic colorectal cancer
  • circulating tumor markers
  • circulating tumor cell
  • circulating tumor DNA
  • marker's kinetic
  • Colorectal Neoplasms