Multicenter Tissue Registry in Melanoma

NCT ID: NCT05750511

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-01

Study Completion Date

2025-02-01

Brief Summary

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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

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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.

Conditions

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Metastatic Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

molecular tissue analysis

Intervention Type DIAGNOSTIC_TEST

Interventions

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molecular tissue analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dermatologic Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Schadendorf, MD

Role: STUDY_CHAIR

Dermatologic Cooperative Oncology Group

Locations

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Dept. of Dermatology, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Department of Dermatology, ElbeKliniken - Klinikum Buxtehude

Buxtehude, Lower Saxony, Germany

Site Status RECRUITING

Department of Dermatology, The Saarland University Hospital

Homburg/Saar, Saarland, Germany

Site Status RECRUITING

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

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Dept. of Dermatology, Helios Clinic Erfurt

Erfurt, Thuringia, Germany

Site Status RECRUITING

Department of Dermatology, University Hospital

Augsburg, , Germany

Site Status RECRUITING

Department of Dermatology, University Hospital

Dresden, , Germany

Site Status RECRUITING

Department of dermatology, University Hospital

Essen, , Germany

Site Status RECRUITING

Medizinische Hochschule,dermatologische Klinik und Poliklinik

Hanover, , Germany

Site Status RECRUITING

Department of Dermatology

Ludwigshafen, , Germany

Site Status RECRUITING

Skin Cancer Unit, University Hospital

Mannheim, , Germany

Site Status RECRUITING

Department of Dermatology, University Hospital

Minden, , Germany

Site Status RECRUITING

Department of Dermatology

Oberhausen, , Germany

Site Status RECRUITING

Department of Dermatology

Quedlinburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Selma Ugurel, MD

Role: CONTACT

+49 201 723 85364

Dirk Schadendorf, MD

Role: CONTACT

+49 201 723 4510

Facility Contacts

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Andrea Forschner, MD

Role: primary

+49-7071-2980872

Peter Mohr, MD

Role: primary

+49 4161 7030

Claudia Pfoehler, MD

Role: primary

+49 6841 3801

Patrick Terheyden, MD

Role: primary

+49-451-5002517

Rudolf herbst, MD

Role: primary

+49-361-7814300

Julia Welzel

Role: primary

Friedegund Meier

Role: primary

Selma Ugurel

Role: primary

Inke Grimmelmann, MD

Role: primary

0049(0)511 92 460

Edgar Dippel

Role: primary

Jochen Utikal

Role: primary

Ralf Gutzmer

Role: primary

Alexander Kreuter

Role: primary

Jens Ulrich

Role: primary

Other Identifiers

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CA209-578

Identifier Type: -

Identifier Source: org_study_id

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