NCT06626269

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Digestive Cancer
• Advanced Gynecologic Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood sample	In cohort A: 3 or 4 blood samples (for plasma and PBMC collection) : at baseline (before immunotherapy initiation); at 3 months ; at 12 months; on case of severe or unexpected toxicity. In cohort B: 3 blood sampes (for plasma and PBMC collection): at baseline (before treatment initiation); at 3 months ; at 12 months In cohort C: 2 blood samples (for plasma and PBMC collection) : at baseline (at the time of surgery); at 3 months (after surgery)
OTHER	Tumor tissue	Cohort A and B: 1 tumor block in paraffin at diagnosis + 1 tumor block in paraffin at progression (optional) Cohort C: Fresh tumoral tissue fragments for TIL and CAF + 1 tumor block in paraffin at time of surgery.

Timeline

• Start date: 2025-02-10
• Primary completion: 2030-02-01
• Completion: 2032-02-01
• First posted: 2024-10-03
• Last updated: 2025-06-20

Locations

2 sites across 1 country: France