Multicenter Tissue Registry in Melanoma

NCT05750511 | Unknown

• 1 other identifier: CA209-578
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 14

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.

Conditions

Metastatic Melanoma

Keywords

melanoma; biomarker; tumor tissue; systemic therapy; immune checkpoint therapy; targeted therapy; PD-L1; Tumor mutational burden

Outcome Measures

Primary Outcomes (3)

• BOR

  best overall response (BOR)

  through study completion, an average of 1 year

• PFS

  progression-free survival (PFS)

  through study completion, an average of 1 year

• OS

  overall survival (OS)

  through study completion, an average of 1 year

Study Arms (1)

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

Interventions

molecular tissue analysis DIAGNOSTIC_TEST

metastatic melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with metastatic melanoma stage III or IV suitable for systemic treatment

You may qualify if:

• 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.

Sponsors & Collaborators

• Dermatologic Cooperative Oncology Group: lead

Study Sites (14)

Dept. of Dermatology, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, D-72076, Germany

RECRUITING

Department of Dermatology, ElbeKliniken - Klinikum Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

RECRUITING

Department of Dermatology, The Saarland University Hospital

Homburg/Saar, Saarland, 66424, Germany

RECRUITING

Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, D-23538, Germany

RECRUITING

Dept. of Dermatology, Helios Clinic Erfurt

Erfurt, Thuringia, 99012, Germany

RECRUITING

Department of Dermatology, University Hospital

Augsburg, Germany

RECRUITING

Department of Dermatology, University Hospital

Dresden, Germany

RECRUITING

Department of dermatology, University Hospital

Essen, Germany

RECRUITING

Medizinische Hochschule,dermatologische Klinik und Poliklinik

Hanover, 30449, Germany

RECRUITING

Department of Dermatology

Ludwigshafen, Germany

RECRUITING

Skin Cancer Unit, University Hospital

Mannheim, Germany

RECRUITING

Department of Dermatology, University Hospital

Minden, Germany

RECRUITING

Department of Dermatology

Oberhausen, Germany

RECRUITING

Department of Dermatology

Quedlinburg, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

pre-treatment tumor tissue of different origin

MeSH Terms

Conditions

Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dirk Schadendorf, MD

  Dermatologic Cooperative Oncology Group

  STUDY CHAIR

Central Study Contacts

Selma Ugurel, MD

CONTACT

+49 201 723 85364; selma.ugurel@uk-essen.de

Dirk Schadendorf, MD

CONTACT

+49 201 723 4510; dirk.schadendorf@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: February 1, 2014
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (14)