Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Substance Related Disorders

Breast Neoplasms

Syndrome

Hand-Foot Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

20 healthy volunteers were included in the healthy control group

30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration

Advanced breast cancer patients with first-line medication

Capecitabine 150Mg Oral Tablet

Yunwei Wei, doctor

xin Wu

Yunwei Wei

To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy.

To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy

Study on Skin Microbiome of HFS

Study on Skin Microbiota of Hand Foot Syndrome

Sponsor GmbH

First Affiliated Hospital of Harbin Medical University

Rare Diseases

Melanoma

Vitiligo

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Hypopigmentation

Pigmentation Disorders

Neuroendocrine Tumor

Neuroepithelioma

Hypomelanotic Disorder

Immunomodulating Agents

Adult patients diagnosed with Vitiligo according to usual criteria

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

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

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

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

skin swabs at lesional and non-lesional sites

It will be examined in patients skin swabs sampled on skin

skin swabs on skin

Julien SENESCHAL, MD, PhD

Maya SALEH, PhD

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

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 field of immunotherapy. The development of molecules blocking certain immunological "checkpoints" (checkpoints exerted by the CTLA-4 (Cytotoxic T lymphocytes Associated protein 4) and PD-1 (Programmed cell Death protein 1) has made it possible to obtain a significant improvement of the overall survival (OS) of patients treated for metastatic melanoma. Ipilimumab, an antibody blocking CTLA-4, is the first immunotherapy marketed, demonstrating for the first time a therapeutic response, however in a small number of patients (10 to 15%) and with significant toxicity (25% of grade 3-4). Subsequently, a second generation of more effective checkpoint blockers (30 to 40% good response) and less toxic, anti-PD-1 antibodies (pembrolizumab and nivolumab), quickly obtained a marketing authorization in the first line treatment of metastatic melanoma treatment and recently in an adjuvant situation after lymph node dissection in order to limit the risk of recurrence. However, despite these advances, a certain number of patients do not respond to treatment and it remains difficult to predict this therapeutic response. Furthermore, patients treated with ICI often experience cutaneous immune-related adverse events manifesting as skin rash, dermatitis, epidermal necrolysis, and in some cases as vitiligo like depigmentation of the skin, testifying to the development of a specific immunogenicity towards the melanocytes, cells causing melanoma, and responsible for a discoloration of the skin. Several studies have reported that a modification of certain bacteria in the digestive microbiota was predictive of the antitumor response to immunotherapy, while others were predictive of the appearance of significant autoimmune ICI-related toxicities (colitis). Several phase 1 studies have evaluated the impact of taking probiotics or fecal transplants on the tumor response of patients receiving immunotherapy for cancer (NCT 03819296; NCT03817125; NCT03643289). Thus by these new concepts, it would be interesting to assess the composition of the skin microbiota in patients treated with anti-PD-1 immunotherapy for the management of metastatic melanoma and developing during their follow-up vitiligo; predictive side effect of improved survival. These data will be compared to those obtained from patients with common vitiligo. This will be examined in patients skin swabs sampled at lesional and non-lesional sites. Functionally, we will characterize the microbial pathways using shotgun sequencing of microbial genomes and meta-transcriptomics (RNA sequencing of microbial communities of the skin).

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.

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

Defining the Role of the Skin Microbiome in Vitiligo and Immune-related Adverse Events in Advanced Melanoma Patients Treated With Anti-PD1

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Skin Microbiome of HFS	NCT04132713	Microbiota	Capecitabine 15...	18 Years - 65 Years	First Affiliated Hospital of Harbin Medical University
Defining the Role of the Skin Microbiome in Immune-related Adverse Events	NCT04734704	Vitiligo Skin Melanoma	skin swabs at l... skin swabs on s...	18 Years -	University Hospital, Bordeaux
Defining the Role of the Skin Microbiome in Immune-related Adverse Events	NCT04734704	Vitiligo Skin Melanoma	skin swabs at l... skin swabs on s...	18 Years -	University Hospital, Bordeaux
Study on Skin Microbiome of HFS	NCT04132713	Microbiota	Capecitabine 15...	18 Years - 65 Years	First Affiliated Hospital of Harbin Medical University

Spots Global Cancer Trial Database for skin microbiota