Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy
The Potential of the Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy, a Pilot Study
This study looks at whether the bacteria naturally present in urine (the "urinary microbiome") can help doctors better understand melanoma, a type of skin cancer, and predict how well patients respond to treatment.
In recent years, researchers have discovered that bacteria in the body-especially in the gut-can influence cancer development and how patients respond to therapy. However, very little is known about the bacteria in urine and whether they may also play a role in cancer.
In this study, patients with melanoma who are starting treatment (such as immunotherapy or targeted therapies) will be asked to provide urine samples and stool samples at several time points, as well as answer questionnaires about their health and lifestyle. A group of people without melanoma will also provide urine samples for comparison.
Researchers will analyze these samples to identify the types of bacteria present and how they change over time. They will then investigate whether certain bacterial patterns are linked to better or worse treatment outcomes.
The study does not change the medical treatment patients receive. Participation mainly involves providing samples and filling out questionnaires, which represents only a small additional effort.
The results of this study may help to identify new, non-invasive biomarkers that could improve early diagnosis and help doctors choose the most effective treatment for melanoma patients in the future
Visão geral do estudo
Status
Condições
Descrição detalhada
This pilot study investigates the urinary microbiome as a potential non-invasive biomarker in patients with melanoma undergoing systemic therapy. It aims to determine whether microbial composition in urine differs between melanoma patients and matched controls, and whether it is associated with and predictive of response to immune checkpoint inhibition or targeted therapy.
In a prospective observational matched cohort design, melanoma patients initiating systemic therapy and control participants are recruited. Patients provide urine and stool samples at baseline and at two follow-up time points during therapy, along with clinical and lifestyle data, while controls provide a single urine sample and questionnaire data. Microbiome profiling is performed using 16S rRNA gene sequencing, followed by bioinformatic and statistical analyses to assess microbial diversity, composition, and associations with clinical variables.
The study evaluates differences in urinary and gut microbiome composition between patients and controls, longitudinal changes during therapy, and associations with treatment response. Statistical approaches include matched analyses, correlation and regression models, and receiver operating characteristic analyses to assess the predictive potential of microbiome-derived biomarkers.
This study is expected to provide first insights into the role of the urinary microbiome in melanoma and its potential utility as a biomarker for diagnosis and prediction of therapeutic response, contributing to the development of personalized treatment strategies.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
-
-
Styria
-
Gratwein, Styria, Áustria, 8036
- Recrutamento
- Department of Dermatology and Venereology, Medical University of Graz
-
Contato:
- Peter Wolf, Prof
- Número de telefone: +433163850
- E-mail: peter.wolf@medunigraz.at
-
Contato:
- Johannes woltsche, MD
- Número de telefone: +433163850
- E-mail: johannes.woltsche@medunigraz.at
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- melanoma with indication for systemic therapy
- age above 18
- informed consent
Exclusion Criteria:
- - inability to provide informed consent
- antibiotic use (except for topical use) ≤ 8 weeks prior to screening
- consumption of probiotic or prebiotic supplements within 4 weeks prior to screening
- current diagnosis of any disease with systemic inflammation (e.g. cellulitis, herpes zoster, psoriasis, etc.)
- for the case group: diagnosis of any active malignancy other than melanoma (except for basal cell carcinoma)
- for the control group: diagnosis of any active malignancy (except for basal cell carcinoma)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Controles
Controles saudáveis
|
|
Immunotherapy
Patients undergoing immunotherapy for melanoma
|
|
targeted therapy
Patients undergoing targeted therapy for melanoma
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Urinary microbiome composition
Prazo: 11-13 weeks
|
Alpha and beta diversity
|
11-13 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Urinary microbiome composition
Prazo: 11-13 weeks
|
Taxonomic composition
|
11-13 weeks
|
|
Gut microbiome composition
Prazo: 11-13 weeks
|
Alpha and beta diversity
|
11-13 weeks
|
|
Gut microbiome composition
Prazo: 11-13 weeks
|
Taxonomic composition
|
11-13 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Melanoma UMB
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .