An observational study in Metastatic Melanoma, sponsored by Dermatologic Cooperative Oncology Group. Status unknown at 14 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Dermatologic Cooperative Oncology Group · Observational
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.
3,005 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 182 across 438 observational studies indexed under Melanoma.
Browse Melanoma studies →Dermatologic Cooperative Oncology Group is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with metastatic melanoma stage III or IV suitable for systemic treatment
Exclusion Criteria:
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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
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
Plan to share: No — patients/samples will be pseudonymized/anonymized
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Dermatologic Cooperative Oncology Group