Back to resultsStudy of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer (Epitopes-CRC01)
Primary Purpose
Metastatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional biological samples
Sponsored by
About this trial
This is an interventional other trial for Metastatic Cancer
Eligibility Criteria
Inclusion Criteria:
For all patients:
- signed written informed consent
For cohort A:
- patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival > or = at 20 months
- Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1
For cohort B:
- patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival < 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)
For cohort C:
- patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy
For cohort D:
- patients with metastatic or locally advanced cancer in complete remission after treatment, non eligible in the other cohorts
Exclusion Criteria:
For all patients:
- patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
- patient with a neurodegenerative disease
- patient under guardianship, curator or under the protection of justice
Sites / Locations
- Centre Hospitalier Universitaire de BesançonRecruiting
- Hôpital Nord Franche ComtéRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Additional biological samples
Arm Description
Additional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart. Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available.
Outcomes
Primary Outcome Measures
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer
progression-free survival
time interval between the date of inclusion and the date of first progression or death from any cause.
Secondary Outcome Measures
Full Information
NCT ID
NCT02838381
First Posted
July 18, 2016
Last Updated
May 10, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02838381
Brief Title
Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
Acronym
Epitopes-CRC01
Official Title
Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Additional biological samples
Arm Type
Other
Arm Description
Additional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart.
Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available.
Intervention Type
Other
Intervention Name(s)
Additional biological samples
Intervention Description
blood and tissue samples
Primary Outcome Measure Information:
Title
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer
Time Frame
at inclusion
Title
progression-free survival
Description
time interval between the date of inclusion and the date of first progression or death from any cause.
Time Frame
within 5 years after the inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For all patients:
signed written informed consent
For cohort A:
patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival > or = at 20 months
Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1
For cohort B:
patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival < 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)
For cohort C:
patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy
For cohort D:
patients with metastatic or locally advanced cancer in complete remission after treatment, non eligible in the other cohorts
Exclusion Criteria:
For all patients:
patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
patient with a neurodegenerative disease
patient under guardianship, curator or under the protection of justice
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe Borg, Pr
Email
christophe.borg@efs.sante.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marine Jary, Dr
Email
mjary@chu-besancon.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BORG, Pr
Facility Name
Hôpital Nord Franche Comté
City
Montbéliard
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BORG, Pr
12. IPD Sharing Statement
Learn more about this trial
Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer
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