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.
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
1,000
Dept. of Dermatology, University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGDepartment of Dermatology, ElbeKliniken - Klinikum Buxtehude
Buxtehude, Lower Saxony, Germany
BOR
best overall response (BOR)
Time frame: through study completion, an average of 1 year
PFS
progression-free survival (PFS)
Time frame: through study completion, an average of 1 year
OS
overall survival (OS)
Time frame: through study completion, an average of 1 year
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Department of Dermatology, The Saarland University Hospital
Homburg/Saar, Saarland, Germany
RECRUITINGDept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
RECRUITINGDept. of Dermatology, Helios Clinic Erfurt
Erfurt, Thuringia, Germany
RECRUITINGDepartment of Dermatology, University Hospital
Augsburg, Germany
RECRUITINGDepartment of Dermatology, University Hospital
Dresden, Germany
RECRUITINGDepartment of dermatology, University Hospital
Essen, Germany
RECRUITINGMedizinische Hochschule,dermatologische Klinik und Poliklinik
Hanover, Germany
RECRUITINGDepartment of Dermatology
Ludwigshafen, Germany
RECRUITING...and 4 more locations