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Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer (Epitopes-CRC02)

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional biological samples
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Hospitalier Régional Universitaire de Besançon
  • Polyclinique de Franche-Comté
  • Hôpitaux Civils de Colmar
  • Centre Georges François Leclerc
  • Hôpital Nord Franche-Comté
  • Institut de Cancérologie de Lorraine
  • Hôpital Européen Georges Pompidou
  • Centre Paul Strauss
  • Centre Hospitalier Universitaire de Tours

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Additional biological samples

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2016
Last Updated
May 10, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02817178
Brief Title
Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
Acronym
Epitopes-CRC02
Official Title
Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 11, 2017 (Actual)
Study Completion Date
July 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal 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
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Additional biological samples
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Additional biological samples
Intervention Description
blood and tumor tissue samples
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
date of first progression of the disease (within 3 years after the enrollment in the study)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano KIM, Dr
Organizational Affiliation
CHU de Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional Universitaire de Besançon
City
Besançon
Country
France
Facility Name
Polyclinique de Franche-Comté
City
Besançon
Country
France
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Nancy
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Centre Hospitalier Universitaire de Tours
City
Tours
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33229508
Citation
Kroemer M, Turco C, Spehner L, Viot J, Idirene I, Bouard A, Renaude E, Deschamps M, Godet Y, Adotevi O, Limat S, Heyd B, Jary M, Loyon R, Borg C. Investigation of the prognostic value of CD4 T cell subsets expanded from tumor-infiltrating lymphocytes of colorectal cancer liver metastases. J Immunother Cancer. 2020 Nov;8(2):e001478. doi: 10.1136/jitc-2020-001478.
Results Reference
derived

Learn more about this trial

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

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