Multicenter Tissue Registry in Melanoma

Recruiting

• Conditions: Metastatic Melanoma
• Interventions: Diagnostic Test: molecular tissue analysis

• Registration Number: NCT05750511
• Lead Sponsor: Dermatologic Cooperative Oncology Group

Brief 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.

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 Timeline

• Study Start: 2014-02-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-18
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
BOR	through study completion, an average of 1 year	best overall response (BOR)
OS	through study completion, an average of 1 year	overall survival (OS)
PFS	through study completion, an average of 1 year	progression-free survival (PFS)

Trial Locations

Locations (10)

Department of Dermatology, University Hospital; 🇩🇪 Minden, Germany

Skin Cancer Unit, University Hospital; 🇩🇪 Mannheim, Germany

Department of Dermatology, ElbeKliniken - Klinikum Buxtehude; 🇩🇪 Buxtehude, Niedersachsen, Germany

Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Department of Dermatology, The Saarland University Hospital; 🇩🇪 Homburg/Saar, Saarland, Germany

Dept. of Dermatology, Helios Clinic Erfurt; 🇩🇪 Erfurt, Thuringia, Germany

Dept. of Dermatology, University Hospital Tuebingen; 🇩🇪 Tuebingen, Baden-Württemberg, Germany

Department of dermatology, University Hospital; 🇩🇪 Essen, Germany

Medizinische Hochschule,dermatologische Klinik und Poliklinik; 🇩🇪 Hannover, Germany

Department of Dermatology; 🇩🇪 Quedlinburg, Germany