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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2020-07-06

Brief Summary

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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 OncoImmunology 2012 and unpublished data).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.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Additional biological samples

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.

Group Type OTHER

Additional biological samples

Intervention Type OTHER

blood and tumor tissue samples

Interventions

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Additional biological samples

blood and tumor tissue samples

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No