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

Not Applicable

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: Additional biological samples

• Registration Number: NCT02817178
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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 OncoImmunology 2012 and unpublished data).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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Primary Completion: 2017-06-11
• Study Completion: 2020-07-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Additional biological samples	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	date of first progression of the disease (within 3 years after the enrollment in the study)]	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.

Trial Locations

Locations (9)

Polyclinique de Franche-Comté; 🇫🇷 Besançon, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Institut de Cancérologie de Lorraine; 🇫🇷 Nancy, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Centre Hospitalier Universitaire de Tours; 🇫🇷 Tours, France