Melanoma of SkinNCT06765850
The Study Aims to Measure the Metabolome in Melanoma Patients Using NMR Spectroscopy and Gas Chromatography and to Analyse Differences Depending on the Course of the Disease.
An observational study of Melanoma of Skin, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Prospective, single-centre study with the central question of how the metabolome from blood samples, different body fluids and tissues between patients patients with malignant melanoma in different tumour tumour stages and healthy patients and whether this is suitable for early detection of initial diagnosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma of Skin
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jul 2022to Jun 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving ongoing tumour therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital
Who may be able to join
- Current or past history of melanoma
- Ongoing therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital
Who cannot join
- Refusal to participate in the study
- Lack of capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Carl Gustav Carus
Dresden, Saxony, 01307
Frank Friedrich Gellrich, Dr. med., +493514582497, frankfriedrich.gellrich@ukdd.de
Frank Friedrich Gellrich, Dr. med.
About this study
Official title: Measurement of the Metabolome in Melanoma Patients Using NMR Spectroscopy and Gas Chromatography.
Prospective, single-centre study with the central question of how the metabolome from blood samples, different body fluids and tissues between patients patients with malignant melanoma in different tumour tumour stages and healthy patients and whether this is suitable for early detection of initial diagnosis, recurrence or stage shift at an early stage.
The biosamples are collected in the BioBank Dresden and used for the NMR and LC-MS analyses described here. It is planned to use the biosamples for further analyses.
- Conditions
- Melanoma of Skin
- Keywords
- Melanoma, Metabolomics, NMR
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in metabolite concentrations
Metabolite concentrations are measured by NMR spectroscopy and gas chromatography and compared between different subgroups.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start4 Jul 2022
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma of SkinStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus
- Responsible party
- Principal investigator, Frank Friedrich Gellrich, University Hospital Carl Gustav Carus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765850
- Sponsor's protocol ID
- Melanomix
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Metabolome in Melanoma Patients Using NMR Spectroscopy and Gas Chromatography.
- ClinicalTrials.gov ID
- NCT06765850
- Acronym / sponsor ID
- Melanomix
- Conditions
- Melanoma of Skin
- Keywords
- Melanoma, Metabolomics, NMR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jan 2025 (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.
Prospective, single-centre study with the central question of how the metabolome from blood samples, different body fluids and tissues between patients patients with malignant melanoma in different tumour tumour stages and healthy patients and whether this is suitable for early detection of initial diagnosis, recurrence or stage shift at an early stage.
The biosamples are collected in the BioBank Dresden and used for the NMR and LC-MS analyses described here. It is planned to use the biosamples for further analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving ongoing tumour therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital
Key inclusion criteria (2 listed)
- Current or past history of melanoma
- Ongoing therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Lack of capacity to consent
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
Differences in metabolite concentrations
Time frame: through study completion, an average of 3 years
Metabolite concentrations are measured by NMR spectroscopy and gas chromatography and compared between different subgroups.
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 Jan 2025.
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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.
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 of Skin, run by Technische Universität Dresden at 1 site in Germany.
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 2 inclusion and 2 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 Jan 2025. 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 Germany. 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?
Contact Frank Friedrich Gellrich, Dr. med. (+493514582497, frankfriedrich.gellrich@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in metabolite concentrations (time frame: through study completion, an average of 3 years). 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 Jan 2025.