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.

NCT06765850 | Recruiting

• 1 other identifier: Melanomix
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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, 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

Outcome Measures

Primary Outcomes (1)

• Differences in metabolite concentrations

  Metabolite concentrations are measured by NMR spectroscopy and gas chromatography and compared between different subgroups.

  through study completion, an average of 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Refusal to participate in the study
• Lack of capacity to consent

Sponsors & Collaborators

• Technische Universität Dresden: lead
• University Hospital Carl Gustav Carus: collaborator

Study Sites (1)

University Hospital Carl Gustav Carus

Dresden, Saxony, 01307, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, various body fluids and tumour tissue

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Frank Friedrich Gellrich, Dr. med.

CONTACT

+493514582497; frankfriedrich.gellrich@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician in Dermatology and Medical Tumor Therapy, Principal Investigator, MD

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 9, 2025
• Study Start: July 4, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

DE (1)