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

Plain-language summary

This study investigates, using blood and tissue samples, the value of IL4I1 gene expression in predicting disease course and response to immune checkpoint inhibitors in patients with cutaneous melanoma (skin melanoma). It enrolled patients with thin or thick primary melanoma, as well as patients receiving immunotherapy for advanced melanoma. It was a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Assistance Publique - Hôpitaux de Paris

Intervention

Blood sample, Cutaneous melanoma biopsy

Start date

4/12/2022

Estimated completion

11/4/2024

Countries

France

Related genes

Locations

• Paris, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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