Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses. The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data). Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.

Official Title
-----------------
Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Additional biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Performance status ECOG-WHO 0, 1 or 2 Metastatic colorectal cancer Histologically proved signed written informed consent Exclusion Criteria: previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease history of autoimmune disease patients under immunotherapy systemic treatment or immunosuppressive drugs or stopped for less than 6 months to the enrollment in this study. corticoids ≥ 1mg/kg acute or chronic infectious disease during treatment or stopped for less than six months other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. pregnancy, breast-feeding or absence of adequate contraception for fertile patients patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study. patient under guardianship, curator or under the protection of justice.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Additional biological samples<br>Additional blood samples will be realized specifically to the study at baseline, at 1 month, at 3 months, and 1 month after surgery (if applicable). Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected. Tissue tumor is collected during surgery if applicable. | Other: Additional biological samples<br>* blood and tumor tissue samples<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause. | date of first progression of the disease (within 3 years after the enrollment in the study)] |