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Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

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

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

NCT02817178•Centre Hospitalier Universitaire de Besancon

View on ClinicalTrials.gov

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 OncoImmunology 2012 and unpublished data).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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Polyclinique de Franche-Comté

Besançon, France

Hôpitaux Civils de Colmar

Colmar, France

Centre Georges François Leclerc

Dijon, France

Hôpital Nord Franche-Comté

Montbéliard, France

Institut de Cancérologie de Lorraine

Nancy, France

Hôpital Européen Georges Pompidou

Paris, France

Centre Paul Strauss

Strasbourg, France

Centre Hospitalier Universitaire de Tours

Tours, France

Key Dates

Start Date

March 1, 2013

Primary Completion Date

June 11, 2017

Completion Date

July 6, 2020

Last Updated

May 11, 2022

Enrollment

258

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Additional biological samples

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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