Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

3. juni 2026 opdateret af: Medical University of Graz

The Potential of the Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy, a Pilot Study

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

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

This pilot study investigates the urinary microbiome as a potential non-invasive biomarker in patients with melanoma undergoing systemic therapy. It aims to determine whether microbial composition in urine differs between melanoma patients and matched controls, and whether it is associated with and predictive of response to immune checkpoint inhibition or targeted therapy.

In a prospective observational matched cohort design, melanoma patients initiating systemic therapy and control participants are recruited. Patients provide urine and stool samples at baseline and at two follow-up time points during therapy, along with clinical and lifestyle data, while controls provide a single urine sample and questionnaire data. Microbiome profiling is performed using 16S rRNA gene sequencing, followed by bioinformatic and statistical analyses to assess microbial diversity, composition, and associations with clinical variables.

The study evaluates differences in urinary and gut microbiome composition between patients and controls, longitudinal changes during therapy, and associations with treatment response. Statistical approaches include matched analyses, correlation and regression models, and receiver operating characteristic analyses to assess the predictive potential of microbiome-derived biomarkers.

This study is expected to provide first insights into the role of the urinary microbiome in melanoma and its potential utility as a biomarker for diagnosis and prediction of therapeutic response, contributing to the development of personalized treatment strategies.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Østrig
    • Styria
      • Gratwein, Styria, Østrig, 8036

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Kontrolelementer
Sund kontrol
Immunotherapy
Patients undergoing immunotherapy for melanoma
targeted therapy
Patients undergoing targeted therapy for melanoma

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary microbiome composition
Tidsramme: 11-13 weeks
Alpha and beta diversity
11-13 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary microbiome composition
Tidsramme: 11-13 weeks
Taxonomic composition
11-13 weeks
Gut microbiome composition
Tidsramme: 11-13 weeks
Alpha and beta diversity
11-13 weeks
Gut microbiome composition
Tidsramme: 11-13 weeks
Taxonomic composition
11-13 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Graz

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. maj 2025

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2030

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Melanoma UMB

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Sequencing data will be deposited in an open repository

IPD-delingstidsramme

after acceptance of the mansucript

IPD-delingsadgangskriterier

open

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Melanom trin IV

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Saudi Arabia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner