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Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma

NCT04920162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-22

No results posted yet for this study

Summary

Skin diseases can have various origins. However, a number of them are linked to an imbalance in the immune system which will lead to either an excessively strong autoimmune response or a complete lack of response against cancer cells. Indeed, both melanoma and vitiligo are pathologies where the immune system plays an important role in the progression of the disease.

Advanced stage melanoma (metastatic lymph node and / or visceral) have a poor prognosis. Although targeted therapies and immunotherapies have improved the outcome for patient however significant proportion of these patients (\~ 50%) developed resistance to therapies.

Vitiligo is a relatively common dermatosis affecting approximately 0.5% to 1% of the French population. Vitiligo results from the destruction of the melanocytes by the immune system. It is manifested by acquired depigmented macules, well limited and asymptomatic. Patients suffering from this condition have a marked decrease in their quality of life. There has been shown a strong link between vitiligo and melanoma. Indeed, patients with melanoma who develop vitiligo (\~ 9% of patients treated with anti-PD-1 drugs) have a better prognosis compared to patients who do not develop vitiligo.

Interestingly, in melanoma cases where the immune system is inactive, the investigators have identified a new molecule secreted by melanoma cells, ITGBL1, leading to the exclusion of immune cells, decreased cytokines secretion and decreased immune cell activation. It is therefore essential to better understand the regulatory mechanism of the immune system in patients with vitiligo or in patients with melanoma treated by immunotherapy in order to be able to propose new therapeutic solutions for these patients.

No study to date has investigated the expression of ITGBL1 and serum inflammatory markers during the development of melanoma. Likewise in vitiligo, if a loss of ITGBL1 is observed, new treatments could be developed in order to limit the progression of the disease by re-expressing this protein.

Thus, the investigators exploratory study will provide the first answers to the predictive value of these markers for these pathologies in order to adapt and develop new treatments.

Conditions

  • Melanoma and Vitiligo

Interventions

OTHER

Biospecimen into patients who had skin diseases

Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-28
Primary Completion
2024-04-05
Completion
2024-04-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04920162 on ClinicalTrials.gov