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

NCT04734704 | Unknown

• 1 other identifier: CHUBX 2020/41
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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 receiving anti-PD-1 for metastatic melanoma

Conditions

Vitiligo; Skin Melanoma

Keywords

immunotherapy; checkpoint inhibitors; vitiligo; skin microbiota; metastatic melanoma.

Outcome Measures

Primary Outcomes (1)

• Determine skin microbiota by sequencing with vitiligo in advanced melanoma patients under immune-checkpoint inhibitors (ICI) immunotherapy.

  The composition of the skin microbiota will be characterized on skin swabs using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).

  Day 1

Study Arms (4)

vitiligo patients

EXPERIMENTAL

Adult patients diagnosed with Vitiligo according to usual criteria

Procedure: skin swabs at lesional and non-lesional sites

metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs

EXPERIMENTAL

metastatic melanoma patients under anti-PD-1 who did not develop Cutaneous Immune-Related Adverse Events (cutaneous irAEs).

Procedure: skin swabs on skin

Metastatic melanoma patients under anti-PD-1 who developed vitiligo lesions

EXPERIMENTAL

patients with metastatic melanoma, under anti-PD-1 who developed vitiligo lesions

Procedure: skin swabs at lesional and non-lesional sites

metastatic melanoma patients with vitiligo lesions under anti-PD-1 who discontinued

EXPERIMENTAL

Metastatic melanoma who developed vitiligo lesions under anti-PD-1 who discontinued the treatment

Procedure: skin swabs at lesional and non-lesional sites

Interventions

skin swabs at lesional and non-lesional sites PROCEDURE

It will be examined in patients skin swabs sampled at lesional and non-lesional sites

Metastatic melanoma patients under anti-PD-1 who developed vitiligo lesions; metastatic melanoma patients with vitiligo lesions under anti-PD-1 who discontinued; vitiligo patients

skin swabs on skin PROCEDURE

It will be examined in patients skin swabs sampled on skin

metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Service de Dermatologie - Hôpital Saint-André

Bordeaux, 33075, France

Location

MeSH Terms

Conditions

Vitiligo; Melanoma

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site

Study Officials

• Julien SENESCHAL, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien SENESCHAL, MD, PhD

CONTACT

+335 57 82 25 00; julien.seneschal@chu-bordeaux.fr

Maya SALEH, PhD

CONTACT

+335 57 57 11 24; maya.saleh@u-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Monocentric (CHU de Bordeaux, Department of dermatology ), with 4 groups : * vitiligo patients * Metastatic melanoma patients receiving anti-PD-1 but without cutaneous irAEs * Metastatic melanoma patients receiving anti-PD-1 who developed vitiligo lesions * metastatic melanoma patients who developed vitiligo under anti-PD-1, who discontinued the treatment.

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)