Identification of Innovative Biomarkers Related to the Immune System or Tumor Microenvironment to Promote the Efficacy of Immunotherapies

Not Applicable

Not yet recruiting

• Conditions: Advanced Digestive Cancer; Advanced Gynecologic Cancer
• Interventions: Diagnostic Test: Blood sample; Other: Tumor tissue

• Registration Number: NCT06626269
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The immune system may be involved in the recognition and destruction of tumor cells or cells undergoing transformation. It is also currently accepted that the quality of immune responses can influence the evolution of cancers after chemotherapy.

In this context, it is possible to assess the presence of specific T cells in patients\' blood and to correlate the presence of specific memory lymphocytes with the quality of long-term clinical protection.

The analysis of immune responses can also be based on i) analysis of the tumor microenvironment (analysis of surgical samples or biopsies) or ii) analysis of molecules secreted in plasma.

Today, the immunotherapies can generate clinical responses in several cancers (for 15 to 25% of patients with melanomas, bladder, lung, kidney or gastric cancers). But the development of these drugs raises two unresolved questions: i) what immunological parameters predict the efficacy of these treatments? ii) why do some cancers remain refractory to the efficacy of these immunomodulatory drugs? It is therefore necessary to identify biomarkers for prognostic stratification and monitoring of patients treated by immunotherapy.

The primary objective of our research team is to identify biomarkers related to the immune system or tumor microenvironment in order to better define patient eligibility criteria for immunotherapy strategies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Study Start: 2025-01
• Primary Completion: 2030-01
• Study Completion: 2032-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
blood test	Blood sample	In cohort A: patients with advanced digestive or gynecological cancers eligible to immunotherapies. In cohort B: patients with advanced digestive or gynecological cancers eligible to treatment without immunotherapy. In cohort C: patients with advanced digestive or gynecological cancers eligible to surgery of metastasis after chemotherapy.
blood test	Tumor tissue	In cohort A: patients with advanced digestive or gynecological cancers eligible to immunotherapies. In cohort B: patients with advanced digestive or gynecological cancers eligible to treatment without immunotherapy. In cohort C: patients with advanced digestive or gynecological cancers eligible to surgery of metastasis after chemotherapy.

Primary Outcome Measures

Name	Time	Method
for cohorts A and B: Progression free survival (PFS) at 6 months post treatment initiation	6 months post treatment initiation	Progression free survival (PFS) at 6 months post treatment initiation, defined as: * non progressive alive patients: if patients are alive without progression in the 6 months from the date of treatment initiation; * or progressive or death patients: if patients are identified with a progression or a death in the 6 months from the date of treatment initiation; * patients without progression or death and with follow up bellow than 6 months are not assessable for PFS status at 6 months Progression-free survival (PFS): defined as the delay from the date of treatment initiation to the disease progression or death from any cause whichever occurs first. Alive patient without progression will be censored at last radiological evaluation available showing no progression.
For cohort C: Relapse free survival (RFS) at 6 months after surgery of metastases	6 months after surgery of metastases	RFS: defined as the delay from the date of surgery of metastases to the disease relapse or death from any cause whichever occurs first. Alive patient without relapse will be censored at last radiological evaluation available showing no relapse.

Trial Locations

Locations (2)

University Hospital of Besançon; 🇫🇷 Besancon, France

Georges François Leclerc center; 🇫🇷 Dijon, France