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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Styria
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Gratwein, Styria, L'Autriche, 8036
- Recrutement
- Department of Dermatology and Venereology, Medical University of Graz
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Contact:
- Peter Wolf, Prof
- Numéro de téléphone: +433163850
- E-mail: peter.wolf@medunigraz.at
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Contact:
- Johannes woltsche, MD
- Numéro de téléphone: +433163850
- E-mail: johannes.woltsche@medunigraz.at
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Contrôles
Contrôles sains
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Immunotherapy
Patients undergoing immunotherapy for melanoma
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targeted therapy
Patients undergoing targeted therapy for melanoma
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Urinary microbiome composition
Délai: 11-13 weeks
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Alpha and beta diversity
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11-13 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Urinary microbiome composition
Délai: 11-13 weeks
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Taxonomic composition
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11-13 weeks
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Gut microbiome composition
Délai: 11-13 weeks
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Alpha and beta diversity
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11-13 weeks
|
|
Gut microbiome composition
Délai: 11-13 weeks
|
Taxonomic composition
|
11-13 weeks
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Melanoma UMB
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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