Trial Title:
Multicenter Tissue Registry in Melanoma
NCT ID:
NCT05750511
Condition:
Metastatic Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
melanoma
biomarker
tumor tissue
systemic therapy
immune checkpoint therapy
targeted therapy
PD-L1
Tumor mutational burden
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
molecular tissue analysis
Arm group label:
metastatic melanoma
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.
Criteria for eligibility:
Study pop:
Subjects with metastatic melanoma stage III or IV suitable for systemic treatment
Sampling method:
Probability Sample
Criteria:
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dept. of Dermatology, University Hospital Tuebingen
Address:
City:
Tuebingen
Zip:
D-72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Andrea Forschner, MD
Phone:
+49-7071-2980872
Email:
studienzentrum-derm-onko@med.uni-tuebingen.de
Investigator:
Last name:
Claus Garbe, MD
Email:
Principal Investigator
Facility:
Name:
Department of Dermatology, ElbeKliniken - Klinikum Buxtehude
Address:
City:
Buxtehude
Zip:
21614
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Peter Mohr, MD
Phone:
+49 4161 7030
Email:
p.mohr@elbekliniken.de
Investigator:
Last name:
Peter Mohr, MD
Email:
Principal Investigator
Facility:
Name:
Department of Dermatology, The Saarland University Hospital
Address:
City:
Homburg/Saar
Zip:
66424
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Claudia Pfoehler, MD
Phone:
+49 6841 3801
Email:
hakras@uniklinik-saarland.de
Investigator:
Last name:
Claudia Pfoehler, MD
Email:
Sub-Investigator
Facility:
Name:
Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
Address:
City:
Lübeck
Zip:
D-23538
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Patrick Terheyden, MD
Phone:
+49-451-5002517
Investigator:
Last name:
Sven Krengel, MD
Email:
Principal Investigator
Facility:
Name:
Dept. of Dermatology, Helios Clinic Erfurt
Address:
City:
Erfurt
Zip:
99012
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Rudolf herbst, MD
Phone:
+49-361-7814300
Investigator:
Last name:
Yvonne Kellner, MD
Email:
Sub-Investigator
Facility:
Name:
Department of Dermatology, University Hospital
Address:
City:
Augsburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Julia Welzel
Facility:
Name:
Department of Dermatology, University Hospital
Address:
City:
Dresden
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Friedegund Meier
Facility:
Name:
Department of dermatology, University Hospital
Address:
City:
Essen
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Selma Ugurel
Facility:
Name:
Medizinische Hochschule,dermatologische Klinik und Poliklinik
Address:
City:
Hannover
Zip:
30449
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Inke Grimmelmann, MD
Phone:
0049(0)511 92 460
Facility:
Name:
Department of Dermatology
Address:
City:
Ludwigshafen
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Edgar Dippel
Facility:
Name:
Skin Cancer Unit, University Hospital
Address:
City:
Mannheim
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jochen Utikal
Facility:
Name:
Department of Dermatology, University Hospital
Address:
City:
Minden
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ralf Gutzmer
Facility:
Name:
Department of Dermatology
Address:
City:
Oberhausen
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alexander Kreuter
Facility:
Name:
Department of Dermatology
Address:
City:
Quedlinburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jens Ulrich
Start date:
February 1, 2014
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Dermatologic Cooperative Oncology Group
Agency class:
Other
Source:
Dermatologic Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05750511
