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

NCT07635732 | Recruiting

• 1 other identifier: Melanoma UMB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma Stage IV

Keywords

microbiome; urinary microbiome; gut microbiome; sequencing; prediction; response; systemic therapy

Outcome Measures

Primary Outcomes (1)

• Urinary microbiome composition

  Alpha and beta diversity

  11-13 weeks

Secondary Outcomes (3)

• Urinary microbiome composition

  11-13 weeks

• Gut microbiome composition

  11-13 weeks

• Gut microbiome composition

  11-13 weeks

Study Arms (3)

Immunotherapy

Patients undergoing immunotherapy for melanoma

targeted therapy

Patients undergoing targeted therapy for melanoma

Controls

Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• melanoma with indication for systemic therapy
• age above 18
• informed consent

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Dermatology and Venereology, Medical University of Graz

Gratwein, Styria, 8036, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, urine, stool

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: May 8, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: after acceptance of the mansucript
• Access Criteria: open

Locations

AU (1)