Status:

UNKNOWN

Defining the Role of the Skin Microbiome in Immune-related Adverse Events

Lead Sponsor:

University Hospital, Bordeaux

Collaborating Sponsors:

Centre National de la Recherche Scientifique, France

Conditions:

Vitiligo

Skin Melanoma

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The skin microbiome has been implicated in several cutaneous autoimmune pathologies such as psoriasis and atopic dermatitis. However, its role in vitiligo and vitiligo lesions occuring in patients rec...

Detailed Description

Melanoma is the most dangerous skin cancer accounting for the highest skin cancer deaths. The prognosis for metastatic melanoma has improved considerably in recent years thanks to advances in the fiel...

Eligibility Criteria

Inclusion

  • Adult patients diagnosed with Vitiligo according to usual criteria.
  • Adult patients with metastatic melanoma, under anti-PD-1 who developed vitiligo
  • Adult patients with metastatic melanoma who did not develop Immune related adverse events under anti-PD-1
  • Adult patients with metastatic melanoma who developed vitiligo under anti-PD-1 and discontinued the treatment
  • Free, informed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion

  • Patients under 18 years old.
  • No treatment for vitiligo in the past 4 weeks
  • Patients under legal protection or unable to express their consent.
  • Patients not affiliated to a health insurance system.
  • Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research.

Key Trial Info

Start Date :

May 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2023

Estimated Enrollment :

175 Patients enrolled

Trial Details

Trial ID

NCT04734704

Start Date

May 1 2021

End Date

May 1 2023

Last Update

February 2 2021

Active Locations (1)

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Service de Dermatologie - Hôpital Saint-André

Bordeaux, France, 33075