Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 11:18 AM
Study NCT ID:
NCT04734704
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2021-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining the Role of the Skin Microbiome in Immune-related Adverse Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014820', 'term': 'Vitiligo'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Monocentric (CHU de Bordeaux, Department of dermatology ), with 4 groups :\n\n* vitiligo patients\n* Metastatic melanoma patients receiving anti-PD-1 but without cutaneous irAEs\n* Metastatic melanoma patients receiving anti-PD-1 who developed vitiligo lesions\n* metastatic melanoma patients who developed vitiligo under anti-PD-1, who discontinued the treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 175}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-01-27', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine skin microbiota by sequencing with vitiligo in advanced melanoma patients under immune-checkpoint inhibitors (ICI) immunotherapy.', 'timeFrame': 'Day 1', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'checkpoint inhibitors', 'vitiligo', 'skin microbiota', 'metastatic melanoma.'], 'conditions': ['Vitiligo', 'Skin Melanoma']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients diagnosed with Vitiligo according to usual criteria.\n* Adult patients with metastatic melanoma, under anti-PD-1 who developed vitiligo\n* Adult patients with metastatic melanoma who did not develop Immune related adverse events under anti-PD-1\n* Adult patients with metastatic melanoma who developed vitiligo under anti-PD-1 and discontinued the treatment\n* Free, informed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Patients under 18 years old.\n* No treatment for vitiligo in the past 4 weeks\n* Patients under legal protection or unable to express their consent.\n* Patients not affiliated to a health insurance system.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04734704', 'acronym': 'SKINBIOTA', 'briefTitle': 'Defining the Role of the Skin Microbiome in Immune-related Adverse Events', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Defining the Role of the Skin Microbiome in Vitiligo and Immune-related Adverse Events in Advanced Melanoma Patients Treated With Anti-PD1', 'orgStudyIdInfo': {'id': 'CHUBX 2020/41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitiligo patients', 'description': 'Adult patients diagnosed with Vitiligo according to usual criteria', 'interventionNames': ['Procedure: skin swabs at lesional and non-lesional sites']}, {'type': 'EXPERIMENTAL', 'label': 'metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs', 'description': 'metastatic melanoma patients under anti-PD-1 who did not develop Cutaneous Immune-Related Adverse Events (cutaneous irAEs).', 'interventionNames': ['Procedure: skin swabs on skin']}, {'type': 'EXPERIMENTAL', 'label': 'Metastatic melanoma patients under anti-PD-1 who developed vitiligo lesions', 'description': 'patients with metastatic melanoma, under anti-PD-1 who developed vitiligo lesions', 'interventionNames': ['Procedure: skin swabs at lesional and non-lesional sites']}, {'type': 'EXPERIMENTAL', 'label': 'metastatic melanoma patients with vitiligo lesions under anti-PD-1 who discontinued', 'description': 'Metastatic melanoma who developed vitiligo lesions under anti-PD-1 who discontinued the treatment', 'interventionNames': ['Procedure: skin swabs at lesional and non-lesional sites']}], 'interventions': [{'name': 'skin swabs at lesional and non-lesional sites', 'type': 'PROCEDURE', 'description': 'It will be examined in patients skin swabs sampled at lesional and non-lesional sites', 'armGroupLabels': ['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']}, {'name': 'skin swabs on skin', 'type': 'PROCEDURE', 'description': 'It will be examined in patients skin swabs sampled on skin', 'armGroupLabels': ['metastatic melanoma patients under anti-PD-1 who did not develop cutaneous irAEs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Service de Dermatologie - Hôpital Saint-André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Julien SENESCHAL, MD, PhD', 'role': 'CONTACT', 'email': 'julien.seneschal@chu-bordeaux.fr', 'phone': '+335 57 82 25 00'}, {'name': 'Maya SALEH, PhD', 'role': 'CONTACT', 'email': 'maya.saleh@u-bordeaux.fr', 'phone': '+335 57 57 11 24'}], 'overallOfficials': [{'name': 'Julien SENESCHAL, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}