NCT04253080Completed
Expression of IL4 Induced Gene 1 in Patients With Cutaneous Melanoma: Value in Prognosis and/or in Predictive Response to Immune Checkpoint Inhibitors
Impact of the IL4I1 Enzyme Expression in Patients With Cutaneous Melanoma: Prognostic Value and/or Role in Resistance to Current Immunotherapy and Targeted Therapy
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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)).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 127 (actual)
- First submitted
- 31 Jan 2020
- Start date
- 12 Apr 2022
- Primary completion date
- 4 Nov 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Melanoma
- NCT number
- NCT04253080
What you commit to
- Study type: Interventional
- Participants enrolled: 127
- From 12 Apr 2022 to the primary completion date, 4 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dermatology Department Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.