Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer (Coca-Colon)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01212510
First received: September 29, 2010
Last updated: June 18, 2014
Last verified: June 2014

September 29, 2010
June 18, 2014
October 2010
October 2015   (final data collection date for primary outcome measure)
Prediction of tumor progression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
sensitivity and specificity of CEA kinetic to predict tumor progression at 3 months (RECIST)
Same as current
Complete list of historical versions of study NCT01212510 on ClinicalTrials.gov Archive Site
Prediction of tumor response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
sensitivity and specificity of CEA kinetic to predict tumor response at 3 months (RECIST)
Same as current
Not Provided
Not Provided
 
Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer
Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

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.

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
Not Provided
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Metastatic Colorectal Cancer
Other: Blood sampling
blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA
Tumor markers
measurement of tumor markers ( blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA )
Intervention: Other: Blood sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 95 Years
No
Contact: Pierre MICHEL, Pr +33232889019 pierre.michel@chu-rouen.fr
Contact: Vincent FERRANTI, CRA +33232888265 vincent.ferranti@chu-rouen.fr
France
 
NCT01212510
2009/170/HP
No
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Pierre MICHEL, Pr UH Rouen
University Hospital, Rouen
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP