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Studies

Interventional Recruiting

NCT05029791 on ClinicalTrials.gov

Variations of Immune Infiltrate and Cell Plasticity Markers in Treated Metastatic Melanoma Patients

Official title: Study of Variations of Immune Infiltrate and Cell Plasticity Markers in Patients With Metastatic Melanoma Under Treatment

  • Sponsor: Hospices Civils de Lyon
  • Enrollment: 100 (Estimated)
  • Study start: 2022-08-18 (Actual)
  • Primary completion: 2031-11-18 (Estimated)
  • Study completion: 2031-11-18 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

COLEMAN is an opened prospective monocentric non-randomized study, initiated by the Hospices Civils de Lyon. Population targeted are patients from 18 years old with stage III or IV metastatic melanoma eligible for a metastatic melanoma treatment administered as part of usual care.

The objective is to study the variations of immune infiltrate and cell plasticity before and under immunotherapy or targeted therapy. Two biopsies are done before and one month after the treatment initiation and one blood sample is done after the treatment initiation.

100 patients will be included and followed during 5 years.

Conditions

  • Melanoma

Intervention / Treatment

  • Other: Tumor biopsy
  • Other: Blood sample

Primary Outcome Measures

  • CD8+ T cells (Month 1 before chemotherapy)
    Dosage of CD8+ T cells
  • CD8+ T cells (Month 1 after chemotherapy)
    Dosage of CD8+ T cells
  • expression of ZEB1 protein (Month 1 before chemotherapy)
    Dosage of ZEB 1 protein
  • expression of ZEB1 protein (Month 1 after chemotherapy)
    Dosage of ZEB 1 protein

Countries

France

Locations and Investigators