Melanoma Stage IVNCT07635732
Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy
An observational study of Melanoma Stage IV, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage IV
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 8 May 2025to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- melanoma with indication for systemic therapy
- age above 18
- informed consent
Who cannot join
- - 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Dermatology and Venereology, Medical University of Graz
Gratwein, Styria, 8036
Peter Wolf, Prof, +433163850, peter.wolf@medunigraz.at
Johannes woltsche, MD, +433163850, johannes.woltsche@medunigraz.at
About this study
Official title: 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.
Read more
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
Read the detailed description
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.
- Conditions
- Melanoma Stage IV
- Keywords
- microbiome, urinary microbiome, gut microbiome, sequencing, prediction, response, systemic therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy | Patients undergoing immunotherapy for melanoma | |
| targeted therapy | Patients undergoing targeted therapy for melanoma | |
| Controls | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary microbiome composition
Alpha and beta diversity
Measured: 11-13 weeks
Secondary outcomes (3)
Urinary microbiome composition
Taxonomic composition
Measured: 11-13 weeks
Gut microbiome composition
Alpha and beta diversity
Measured: 11-13 weeks
Gut microbiome composition
Taxonomic composition
Measured: 11-13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start8 May 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma Stage IVStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635732
- Sponsor's protocol ID
- Melanoma UMB
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sequencing data will be deposited in an open repository
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of the Urinary Microbiome as a Biomarker for Melanoma Diagnosis and Response Prediction to Systemic Tumour Therapy, a Pilot Study
- ClinicalTrials.gov ID
- NCT07635732
- Acronym / sponsor ID
- Melanoma UMB
- Conditions
- Melanoma Stage IV
- Keywords
- microbiome, urinary microbiome, gut microbiome, sequencing, prediction, response, systemic therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 8 May 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy | – | –Patients undergoing immunotherapy for melanoma |
| targeted therapy | – | –Patients undergoing targeted therapy for melanoma |
| Controls | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- melanoma with indication for systemic therapy
- age above 18
- informed consent
Key exclusion criteria (6 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary microbiome composition
Time frame: 11-13 weeks
Alpha and beta diversity
3 secondary outcomes
Urinary microbiome composition
Time frame: 11-13 weeks
Gut microbiome composition
Time frame: 11-13 weeks
Gut microbiome composition
Time frame: 11-13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. Sequencing data will be deposited in an open repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Dermatology and Venereology, Medical University of Graz
Gratwein, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma Stage IV, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary microbiome composition (time frame: 11-13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.