About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
melanoma with indication for systemic therapy
age above 18
informed consent
Disqualifiers
- 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.)
Trial population
Patients with melanoma who are introduced to immune checkpoint inhibition or targeted therapy at the Department of Dermatology and Venereology at the Medical University of Graz are asked to take part in this observational cohort study. The indication for tumour therapy is chosen independently of the study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Urinary microbiome composition
Alpha and beta diversity
Secondary outcomes
Urinary microbiome composition
Taxonomic composition
Gut microbiome composition
Alpha and beta diversity
Gut microbiome composition
Taxonomic composition
Sponsors and contacts
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