Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Biological | — | UNRESOLVED |
| Cutaneous melanoma biopsy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- patients with primary thin melanoma < or = 1mm
- description
- patients with primary thin melanoma (Breslow thickness less than or equal 1 mm)
- type
- NO_INTERVENTION
- label
- patients with primary thick melanoma > or = 3 mm
- description
- patients with primary thick melanoma (Breslow greater than or equal 3 mm)
- type
- OTHER
- label
- patient with melanoma who received treatment
- description
- patient with melanoma (stages III or IV inoperable) and who received first line treatment with immunotherapy and / or targeted therapies
- interventionNames
- Biological: Blood sample
- Biological: Cutaneous melanoma biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDRamspott JP, Bekkat F, Bod L, Favier M, Terris B, Salomon A, Djerroudi L, Zaenker KS, Richard Y, Molinier-Frenkel V, Castellano F, Avril MF, Prevost-Blondel A. Emerging Role of IL-4-Induced Gene 1 as a Prognostic Biomarker Affecting the Local T-Cell Response in Human Cutaneous Melanoma. J Invest Dermatol. 2018 Dec;138(12):2625-2634. doi: 10.1016/j.jid.2018.06.178. Epub 2018 Jul 23. PMID 30048651
- BACKGROUNDBod L, Lengagne R, Wrobel L, Ramspott JP, Kato M, Avril MF, Castellano F, Molinier-Frenkel V, Prevost-Blondel A. IL4-induced gene 1 promotes tumor growth by shaping the immune microenvironment in melanoma. Oncoimmunology. 2017 Jan 13;6(3):e1278331. doi: 10.1080/2162402X.2016.1278331. eCollection 2017. PMID 28405502