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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Graz

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 3 trial groups
Group A: Immunotherapy
Group B: targeted therapy
Group C: Controls

Trial outcomes

Primary outcomes

1

Urinary microbiome composition

Alpha and beta diversity

Time frame
11-13 weeks

Secondary outcomes

1

Urinary microbiome composition

Taxonomic composition

Time frame
11-13 weeks
2

Gut microbiome composition

Alpha and beta diversity

Time frame
11-13 weeks
3

Gut microbiome composition

Taxonomic composition

Time frame
11-13 weeks

Other outcomes

Sponsors and contacts

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