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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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)).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Dermatology department
RECRUITING
Paris
Contact Information
Primary
Nora Kramkimel, MD, PhD
nora.kramkimel@aphp.fr
+33 1 58 41 19 80
Backup
Christelle Auger
christelle.auger@aphp.fr
+33 1 58 41 11 86
Time Frame
Start Date: 2022-04-12
Estimated Completion Date: 2025-02
Participants
Target number of participants: 170
Treatments
No_intervention: patients with primary thin melanoma < or = 1mm
patients with primary thin melanoma (Breslow thickness less than or equal 1 mm)
No_intervention: patients with primary thick melanoma > or = 3 mm
patients with primary thick melanoma (Breslow greater than or equal 3 mm)
Other: patient with melanoma who received treatment
patient with melanoma (stages III or IV inoperable) and who received first line treatment with immunotherapy and / or targeted therapies
Related Therapeutic Areas
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, Institut Cochin, Société de Dermatologie Française, Association Robert Debré (ARD)
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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