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.

January 3, 2025 updated by: Frank Friedrich Gellrich, Technische Universität Dresden

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.

Study Overview

Status

Recruiting

Conditions

Melanoma of Skin

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Frank Friedrich Gellrich, Dr. med.
Phone Number: +493514582497
Email: frankfriedrich.gellrich@ukdd.de

Study Locations

Germany
- Saxony
  - Dresden, Saxony, Germany, 01307
    - Recruiting
    - University Hospital Carl Gustav Carus
    - Contact:
      
      Frank Friedrich Gellrich, Dr. med.
      
      Phone Number: +493514582497
      
      Email: frankfriedrich.gellrich@ukdd.de
    - Contact:
      
      Frank Friedrich Gellrich, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients receiving ongoing tumour therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital

Description

Inclusion Criteria:

Current or past history of melanoma
Ongoing therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital

Exclusion Criteria:

Refusal to participate in the study
Lack of capacity to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

University Hospital Carl Gustav Carus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)