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COMPLETED

NCT04253080

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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)).

Official title: Impact of the IL4I1 Enzyme Expression in Patients With Cutaneous Melanoma: Prognostic Value and/or Role in Resistance to Current Immunotherapy and Targeted Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

127

Start Date

2022-04-12

Completion Date

2024-11-04

Last Updated

2026-05-20

Healthy Volunteers

Conditions

Cutaneous Melanoma

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.

Inclusion Criteria: * group 1: patients with primary thin melanoma (Breslow thickness less than or equal to1 mm) monitored for 10 years, having relapsed or not within 10 years after the diagnosis. * patients with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma * patient or patient's family (in case of death) informed of the objectives and modalities of the study and not opposed to participation in the study * patient or patient's family (in case of death) not opposed to the use of part of the skin sample previously taken for the present research * group 2: patients with primary thick melanoma (Breslow greater than or equal to 3 mm) monitored for 5 years, having relapsed or not within 5 years after diagnosis. * patient with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma * patient or patient's family (in case of death) informed of the objectives and modalities of the study and not opposed to participation in the study * patient or patient's family (in case of death) not opposed to the use of part of the skin sample previously taken for the present research * group 3: patient with melanoma (stages III or IV inoperable) and who are treated with immunotherapy and / or biotherapy * patient with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma and initiation of systemic treatment for melanoma * patient informed of the objectives and modalities of the study and having given informed and written consent to participate in the study Exclusion Criteria: * groups 1 and 2: patient or family of the patient opposed (e) that part of the primary melanoma taken previously is used in the context of the present project * group 3 : * refusal of the patient to participate in the study * patient unable to understand the study and sign consent * patient with a known contraindication to xylocaine * patient not affiliated to a social security system (beneficiary or beneficiary's right) * adult subject to a legal protection measure

Locations (1)

Dermatology department

Paris, Île-de-France Region, France