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

NCT02838381 | Completed

• 1 other identifier: P/2011/117
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Additional biological samples

OTHER

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

Interventions

Additional biological samples OTHER

blood and tissue samples

Additional biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (2)

Centre Hospitalier Universitaire de Besançon

Besançon, France

Location

Hôpital Nord Franche Comté

Montbéliard, France

Location

Related Publications (1)

• Lopez M, Spehner L, Andre F, Viot J, Seffar E, Marguier A, Curtit E, Meynard G, Dobi E, Ladoire S, Boidot R, Loyon R, Derangere V, Bidard FC, Borg C, Mansi L, Kroemer M. Exploring the role of ESR1 mutations in metastatic hormone receptor-positive breast cancer T cell immune surveillance disruption. Breast Cancer Res. 2025 Feb 7;27(1):19. doi: 10.1186/s13058-025-01962-6.

  PMID: 39920833 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: June 1, 2012
• Primary Completion: December 31, 2023
• Study Completion: June 11, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

FR (2)