Multicenter Tissue Registry in Melanoma (TRIM)

February 28, 2023 updated by: Dermatologic Cooperative Oncology Group

Prospective Multicenter Translational Study to Validate Molecular Biomarkers (TMB, PD-L1) on Pre-treatment Tumor Tissue as Predictors of Therapy Outcome in Metastatic Melanoma Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1000

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

Study Contact Backup

Study Locations

  • Germany
      • Augsburg, Germany
        • Recruiting
        • Department of Dermatology, University Hospital
        • Contact:
          • Julia Welzel
      • Dresden, Germany
        • Recruiting
        • Department of Dermatology, University Hospital
        • Contact:
          • Friedegund Meier
      • Essen, Germany
        • Recruiting
        • Department of Dermatology, University Hospital
        • Contact:
          • Selma Ugurel
      • Hannover, Germany, 30449
        • Recruiting
        • Medizinische Hochschule,dermatologische Klinik und Poliklinik
        • Contact:
          • Inke Grimmelmann, MD
          • Phone Number: 0049(0)511 92 460
      • Ludwigshafen, Germany
        • Recruiting
        • Department of Dermatology
        • Contact:
          • Edgar Dippel
      • Mannheim, Germany
        • Recruiting
        • Skin Cancer Unit, University Hospital
        • Contact:
          • Jochen Utikal
      • Minden, Germany
        • Recruiting
        • Department of Dermatology, University Hospital
        • Contact:
          • Ralf Gutzmer
      • Oberhausen, Germany
        • Recruiting
        • Department of Dermatology
        • Contact:
          • Alexander Kreuter
      • Quedlinburg, Germany
        • Recruiting
        • Department of Dermatology
        • Contact:
          • Jens Ulrich
    • Baden-Württemberg
      • Tuebingen, Baden-Württemberg, Germany, D-72076
    • Niedersachsen
      • Buxtehude, Niedersachsen, Germany, 21614
        • Recruiting
        • Department of Dermatology, ElbeKliniken - Klinikum Buxtehude
        • Principal Investigator:
          • Peter Mohr, MD
        • Contact:
    • Saarland
      • Homburg/Saar, Saarland, Germany, 66424
        • Recruiting
        • Department of Dermatology, The Saarland University Hospital
        • Contact:
        • Sub-Investigator:
          • Claudia Pfoehler, MD
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, D-23538
        • Recruiting
        • Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
        • Principal Investigator:
          • Sven Krengel, MD
        • Contact:
          • Patrick Terheyden, MD
          • Phone Number: +49-451-5002517
    • Thuringia
      • Erfurt, Thuringia, Germany, 99012
        • Recruiting
        • Dept. of Dermatology, Helios Clinic Erfurt
        • Sub-Investigator:
          • Yvonne Kellner, MD
        • Contact:
          • Rudolf herbst, MD
          • Phone Number: +49-361-7814300

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with metastatic melanoma stage III or IV suitable for systemic treatment

Description

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, but older tissue material or primary tumor tissue also possible).
  4. Patient has given written informed consent for the current study as well as for his data to be entered into the ADOREG online database system.
  5. Patient is ≥18 years old.

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
metastatic melanoma
1,000 subjects with metastatic melanoma stage III or IV suitable for systemic treatment from centers of the German Dermatologic Cooperative Oncology Group (DeCOG)
Diagnostic test: molecular tissue analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOR
Time Frame: through study completion, an average of 1 year
best overall response (BOR)
through study completion, an average of 1 year
PFS
Time Frame: through study completion, an average of 1 year
progression-free survival (PFS)
through study completion, an average of 1 year
OS
Time Frame: through study completion, an average of 1 year
overall survival (OS)
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Dermatologic Cooperative Oncology Group

Investigators

  • Study Chair: Dirk Schadendorf, MD, Dermatologic Cooperative Oncology Group

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)

February 1, 2014

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

patients/samples will be pseudonymized/anonymized

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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