TRIM: Multicenter Tissue Registry in Melanoma

Sponsor

Dermatologic Cooperative Oncology Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT05750511

Collaborator

(none)

1,000

Enrollment

Locations

132

Anticipated Duration (Months)

71.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Diagnostic Test: molecular tissue analysis

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with histologically confirmed melanoma stage III or IV.
Clinically eligible for systemic cancer therapy (immune checkpoint inhibitors, targeted agents).
Tumor tissue biopsy already existing (metastasis tissue as recent as possible, but older tissue material or primary tumor tissue also possible).
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.
Patient is ≥18 years old.

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Dermatology, University Hospital Tuebingen	Tuebingen	Baden-Württemberg	Germany	D-72076
2	Department of Dermatology, ElbeKliniken - Klinikum Buxtehude	Buxtehude	Niedersachsen	Germany	21614
3	Department of Dermatology, The Saarland University Hospital	Homburg/Saar	Saarland	Germany	66424
4	Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck	Lübeck	Schleswig-Holstein	Germany	D-23538
5	Dept. of Dermatology, Helios Clinic Erfurt	Erfurt	Thuringia	Germany	99012
6	Department of Dermatology, University Hospital	Augsburg		Germany
7	Department of Dermatology, University Hospital	Dresden		Germany
8	Department of dermatology, University Hospital	Essen		Germany
9	Medizinische Hochschule,dermatologische Klinik und Poliklinik	Hannover		Germany	30449
10	Department of Dermatology	Ludwigshafen		Germany
11	Skin Cancer Unit, University Hospital	Mannheim		Germany
12	Department of Dermatology, University Hospital	Minden		Germany
13	Department of Dermatology	Oberhausen		Germany
14	Department of Dermatology	Quedlinburg		Germany