Multicenter Tissue Registry in Melanoma

Last updated: February 28, 2023
Sponsor: Dermatologic Cooperative Oncology Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Metastatic Melanoma

Treatment

N/A

Clinical Study ID

NCT05750511
CA209-578
  • Ages > 18
  • All Genders

Study Summary

The prospective multicenter translational study Tissue Registry in Melanoma (ADOREG/TRIM; CA209-578) aimed to validate the Tumor Mutational Burden (TMB) and the PD-L1 expression (PD-L1) from a pre-therapeutically obtained tumor tissue sample as a predictor of a subsequent systemic therapy in a large real-world cohort of metastatic melanoma patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with histologically confirmed melanoma stage III or IV.
  2. Clinically eligible for systemic cancer therapy (immune checkpoint inhibitors,targeted agents).
  3. Tumor tissue biopsy already existing (metastasis tissue as recent as possible, butolder tissue material or primary tumor tissue also possible).
  4. Patient has given written informed consent for the current study as well as for hisdata to be entered into the ADOREG online database system.
  5. Patient is ≥18 years old.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 1000
Study Start date:
February 01, 2014
Estimated Completion Date:
February 01, 2025

Study Description

The aim of the present study is to identify and validate molecular and clinical biomarkers of therapy outcome in metastatic melanoma. Clinical and molecular parameters of melanoma patients and their tumors will be collected in an online-based registry (ADOREG), and thereafter correlated with the outcome of subsequent systemic therapies in terms of progression-free survival, overall survival, and treatment response. Systemic therapies will include all types of currently used regimens (kinase inhibitors, immune checkpoint inhibitors, chemotherapy). FFPE tissue samples will comprise different time points (primary tumors versus metastases) as well as tumor sites (lymph node versus organ metastases) to identify potential differences in the predictive value of these materials. The anticipated results from these analyses are of essential importance for future patient selection for individualized therapy strategies.

Connect with a study center

  • Dept. of Dermatology, University Hospital Tuebingen

    Tuebingen, Baden-Württemberg D-72076
    Germany

    Active - Recruiting

  • Department of Dermatology, ElbeKliniken - Klinikum Buxtehude

    Buxtehude, Niedersachsen 21614
    Germany

    Active - Recruiting

  • Department of Dermatology, The Saarland University Hospital

    Homburg/Saar, Saarland 66424
    Germany

    Active - Recruiting

  • Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck

    Lübeck, Schleswig-Holstein D-23538
    Germany

    Active - Recruiting

  • Dept. of Dermatology, Helios Clinic Erfurt

    Erfurt, Thuringia 99012
    Germany

    Active - Recruiting

  • Department of Dermatology, University Hospital

    Augsburg,
    Germany

    Active - Recruiting

  • Department of Dermatology, University Hospital

    Dresden,
    Germany

    Active - Recruiting

  • Department of dermatology, University Hospital

    Essen,
    Germany

    Active - Recruiting

  • Medizinische Hochschule,dermatologische Klinik und Poliklinik

    Hannover, 30449
    Germany

    Active - Recruiting

  • Department of Dermatology

    Ludwigshafen,
    Germany

    Active - Recruiting

  • Skin Cancer Unit, University Hospital

    Mannheim,
    Germany

    Active - Recruiting

  • Department of Dermatology, University Hospital

    Minden,
    Germany

    Active - Recruiting

  • Department of Dermatology

    Oberhausen,
    Germany

    Active - Recruiting

  • Department of Dermatology

    Quedlinburg,
    Germany

    Active - Recruiting

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