Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05029791

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

Led by Hospices Civils de Lyon · Updated on 2023-12-15

100

Participants Needed

1

Research Sites

482 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age �3E= 18
  • Female patients must agree to use two methods of contraception; male patients need one method if their partner is of childbearing age during the study and for at least 5 months after last treatment
  • Patients with metastatic stage III or IV melanoma relapse
  • Eligible for metastatic melanoma treatment as part of usual care
  • Willing and able to undergo cutaneous tumor biopsies (except on face, folds, or lymph nodes)
  • Insured or beneficiary of a health insurance plan
  • Able to provide informed consent and sign approved consent forms
  • Accept conservation and use of biological samples for clinical and genetic research
Not Eligible

You will not qualify if you...

  • Being treated for hematologic tumors
  • Having a documented history of autoimmune disease
  • Diagnosis of ocular melanoma
  • Persons under legal protection (safeguard of justice)
  • Use of immunosuppressants, including corticosteroids, within 4 weeks before inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Service de dermatologie (Bâtiment 1A)

Lyon, France, 69495

Actively Recruiting

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Research Team

S

Stéphane Dalle, Pr

CONTACT

M

Myrtille Le Bouar, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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