Urinary microbiome as a biomarker for melanoma diagnosis and treatment response
Official title: The Potential of the Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy, a Pilot Study
Run by Medical University of Graz · NCT07635732 · Data updated 2026-11-12
This study tests whether bacteria in urine can help diagnose melanoma and predict how well patients will respond to systemic therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Gratwein, Styria) |
| Status | Recruiting |
| Started | May 8, 2025 |
| Main results expected | May 2028 |
| Study ends | May 2030 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07635732 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with melanoma stage IV who are starting systemic therapy and can provide urine and stool samples, with informed consent.
✕Probably not a fit
Patients who do not show a microbiome signal related to their treatment response or who cannot provide samples may not receive predictive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, matched-cohort study in adults with stage IV melanoma starting systemic therapy. Researchers will collect urine and stool samples at baseline and during treatment, plus health questionnaires, and compare them with samples from matched controls without melanoma. Microbiome profiles will be generated from 16S rRNA sequencing and analyzed for diversity, composition, and associations with treatment response. The goal is to see if urinary and gut bacteria patterns differ between patients and controls and whether they predict response to immunotherapy or targeted therapies.
Why it matters
Potential benefit: If successful, urinary microbiome patterns could become non-invasive biomarkers to help diagnose melanoma and predict treatment responses.
How similar studies have gone: Other cancer microbiome studies have shown promise in linking gut bacteria to treatment response, but urinary microbiome biomarkers in melanoma are still exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Department of Dermatology and Venereology, Medical University of Graz
Gratwein, Styria, Austria Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.