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

Study Overview
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Brief Summary
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The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.

Detailed Description
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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.

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

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tumor markers<br>measurement of tumor markers ( blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA ) | Other: Blood sampling<br>* blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of tumor progression | sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of tumor response | sensitivity and specificity of CEA kinetic to predict tumor response at 3 months (RECIST) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic colorectal cancer, circulating tumor markers, circulating tumor cell, circulating tumor DNA, marker's kinetic