Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer (Epitopes-CRC01)

The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer
• Intervention / Treatment: Other: Additional biological samples

• Study Type: Interventional
• Enrollment (Actual): 553
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Centre Hospitalier Universitaire de Besancon
  • Montbéliard, France
    • Hopital Nord Franche Comte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

For all patients:

• signed written informed consent

For cohort A:

• patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival > or = at 20 months
• Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1

For cohort B:

• patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival < 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)

For cohort C:

• patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy

For cohort D:

• patients with metastatic or locally advanced cancer in complete remission after treatment, non eligible in the other cohorts

Exclusion Criteria:

For all patients:

• patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
• patient with a neurodegenerative disease
• patient under guardianship, curator or under the protection of justice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Additional biological samples; Additional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart. Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available.	Other: Additional biological samples; blood and tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer		at inclusion
progression-free survival	time interval between the date of inclusion and the date of first progression or death from any cause.	within 5 years after the inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besançon

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimated): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasms, Second Primary; Neoplasm Metastasis
• Other Study ID Numbers: P/2011/117