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
  Purpose

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.


Condition Intervention
Metastatic Colorectal Cancer
Other: Blood sampling

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 500
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tumor markers
measurement of tumor markers ( blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA )
Other: Blood sampling
blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212510

Contacts
Contact: Pierre MICHEL, Pr +33232889019 pierre.michel@chu-rouen.fr
Contact: Vincent FERRANTI, CRA +33232888265 vincent.ferranti@chu-rouen.fr

Locations
France
Centre François Baclesse Not yet recruiting
Caen, France, 14000
Contact: Marie-Pierre Gallais, Dr    +33231455154    Mp.gallais@baclesse.fr   
Principal Investigator: Marie P Gallais, Dr         
Sub-Investigator: Anne C Lefebvre, Dr         
Sub-Investigator: Jacques H Jacob, Dr         
University Hospital Not yet recruiting
Caen, France, 14000
Contact: Dominique Arsène, Dr    +33231065340      
Principal Investigator: Dominique Arsène, Dr         
Centre Frédéric Joliot Recruiting
Rouen, France, 76000
Contact: Laurent BASTIT, Dr    +33232764076    lbastit@frederic-joliot.fr   
Principal Investigator: Laurent BASTIT, Dr         
Sub-Investigator: Orlane Clouet, Dr         
Sub-Investigator: Philippe Gomez, Dr         
Sub-Investigator: Abderraouf Radji, Dr         
Sub-Investigator: Harizo Randrianarivelo, Dr         
Sub-Investigator: Aude Toulemonde, Dr         
University Hospital Not yet recruiting
Rouen, France, 76000
Contact: Pierre MICHEL, Pr    +33232889019    pierre.michel@chu-rouen.fr   
Principal Investigator: Pierre Michel, Pr         
Sub-Investigator: Frédéric Di Fiore, Dr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Pierre MICHEL, Pr UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01212510     History of Changes
Other Study ID Numbers: 2009/170/HP
Study First Received: September 29, 2010
Last Updated: June 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
metastatic colorectal cancer
circulating tumor markers
circulating tumor cell
circulating tumor DNA
marker's kinetic

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014