Evaluating Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Treatment Response Prediction in Patients Receiving Systemic Therapy

What this Trial Is About

Researchers are investigating whether the bacteria naturally found in urine, known as the urinary microbiome, can help improve understanding of melanoma, a type of skin cancer, and predict how patients respond to treatments like immunotherapy or targeted therapy. This pilot observational study focuses on patients with melanoma who are starting systemic therapy and compares their urinary bacterial patterns to those of people without melanoma. The study aims to identify potential non-invasive biomarkers that could support early diagnosis and personalized treatment decisions. Participants include melanoma patients undergoing immunotherapy or targeted therapy, as well as a control group without melanoma. Melanoma patients will provide urine and stool samples at the start of therapy and at two additional time points during treatment, along with clinical and lifestyle questionnaires. Controls will provide one urine sample and complete a questionnaire. The study uses advanced gene sequencing and statistical methods to analyze bacterial diversity, composition, and links to treatment outcomes. Participants mainly contribute by providing biological samples and answering questionnaires, which requires minimal additional effort beyond their usual care. Researchers will monitor changes in the urinary and gut microbiomes over approximately 11 to 13 weeks, comparing these to treatment responses. This study does not alter medical treatments but aims to find bacterial patterns that might predict therapy success, helping to tailor future melanoma treatments.

Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy