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Expression of IL4 Induced Gene 1 in Patients With Cutaneous Melanoma: Value in Prognosis and/or in Predictive Response to Immune Checkpoint Inhibitors

NCT04253080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-05-20

No results posted yet for this study

Summary

To characterize and quantify immune cells expressing the Interleukine 4 induced gene 1 (IL4I1) immunosuppressive enzyme in the blood and in tissue of melanoma patients (primary tumor, sentinel lymph nodes and cutaneous metastases).

Then, to compare the results obtained in different clinical settings:

* in cases of progression of the disease slower or faster compared to the prognosis established by clinical and pathological data
* before and after treatments with immunotherapy (anti Programmed Death ligand 1 (anti-PD1) or anti-PD1 and anti Cytotoxic T Lymphocyte associated protein 4 (anti-CTLA-4)) and / or targeted therapies (BRAF inhibitors and /or methyl ethyl ketone (MEK)).

Conditions

Interventions

BIOLOGICAL

Blood sample

Blood sample before treatment, 3 months after treatment and after 1 year or relapse or resumption of disease progression.

BIOLOGICAL

Cutaneous melanoma biopsy

Cutaneous melanoma biopsy before treatment, 3 months after treatment and relapse or resumption of disease progression.

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Association Robert Debré (ARD)

    collaborator UNKNOWN

  • Société de Dermatologie Française

    collaborator OTHER

  • Institut Cochin

    collaborator OTHER

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Armelle Blondel, MD, PhD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2024-11-04
Completion
2024-11-04

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253080 on ClinicalTrials.gov