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

Not Applicable

Completed

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

• Registration Number: NCT02838381
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 553

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 & 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 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.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France

Hôpital Nord Franche Comté; 🇫🇷 Montbéliard, France