Registers for Documenting and Improving the Treatment of Skin Cancer in Germany
- Gender
- Women and men
- Age
- 18–80 years
- Trial type
- Observational
- Line of therapy
- all
- Phase
- —
What is this trial about?
The gold standard for treating malignant melanoma is surgical removal. Especially in advanced stages of the disease, additional immunotherapy, radiation therapy, or drug treatment may be necessary. Currently, data on the treatments used are not collected, making it difficult for treating physicians to exchange information and compare outcomes. The goal of the ADOREG study is to centrally record all treatment protocols for dermatological tumors and to incorporate this information into future studies. Patients between the ages of 18 and 80 who have malignant melanoma (stage IIB or higher), an epithelial tumor, or actinic keratosis are eligible to participate.
Trial flow
Requirements
Diagnosis: Skin cancer
Age: 18–80 years
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: Malignant Melanoma, Epithelial Tumors and Actinic Keratosis
Allocation
Einarmige Studie
Treatment
Follow-up
Diagnosis: Skin cancer
Age: 18–80 years
Line of therapy: Unabhängig von Therapielinie
Key inclusion criteria: Malignant Melanoma, Epithelial Tumors and Actinic Keratosis
Einarmige Studie
Detailed description
Malignant melanoma is a cancerous skin disease that originates in melanocytes (specialized skin cells that contain the pigment melanin). The staging of malignant melanoma is based on the depth of the tumor, associated skin lesions (ulcerations), and the presence of metastases (distant spread of cancer cells to other tissues). The treatment of malignant melanoma depends on numerous factors. Among other things, treatment is guided by the stage of the cancer, the presence of certain genetic mutations, and the patient’s overall physical condition. Surgical removal of the tumor is the gold standard for treating malignant melanoma and is generally aimed at complete recovery (curative). This involves removing the cancer with a sufficient safety margin and, if necessary, surrounding lymph nodes. If this is not possible, further surgery and, if necessary, radiation therapy are performed. Stage IIB is considered an advanced stage, with an increased risk of metastases and recurrence. For this reason, starting at this stage, additional medications may be used to combat the primary tumor or metastases, such as immunotherapy. Immunotherapy strengthens or modifies the body’s own immune system to help fight cancer cells. The follow-up examinations scheduled after treatment are also planned based on the stage of the disease. Actinic keratosis is a rough, scaly skin lesion caused primarily by sun exposure and can be considered a precursor to skin cancer. Epithelial tumors refer to a broad category of growths originating from the surface skin cells (epithelial cells), which can be either benign or malignant.
The fact that treatment approaches can vary greatly from patient to patient and that treatment outcomes from different treatment centers are not centrally collected makes it difficult to compare the efficacy and safety of treatments. The goal of the ADOREG study is to centrally record and document all treatment processes for dermatological tumors by establishing a registry, thereby enabling scientific evaluation. The multicenter use of this database is intended to lay the groundwork for future studies and to continuously improve patient care. The study is being conducted using three sub-registers (malignant melanoma, epithelial tumors, actinic keratosis) and is observational only. This means that no specific treatment will be administered as part of the study. The exact treatment plan will continue to be determined by the treating physicians after consulting with you. The study is ongoing, and no primary endpoint has been defined. Men and women between the ages of 18 and 80 are eligible to participate in this study. During the pilot phase, only patients with malignant melanoma (stage IIB or higher) will be recruited. As the study progresses, individuals with epithelial tumors or actinic keratosis will also be recruited.
Facts
- What condition: malignant melanoma, epithelial tumors, actinic keratosis
- Cancer characteristics: malignant melanoma, stage IIB or higher
- What the study investigates: centralized recording of all treatment protocols for dermatological tumors in routine clinical practice
- Study objective: to create a centralized database as a foundation for future prospective studies aimed at improving care and treatment
- Study duration: ongoing, no primary endpoint
- Study characteristics: non-interventional observational study with centralized data collection in a registry; no specific therapy provided as part of the study
Trial sites
15 trial sites in Germany are listed. Find a site near you.
Universitätsklinikum Augsburg
Stenglinstraße 2, 86156 Augsburg
RecruitingDermatologie
Buxtehude
Status unknownDermatologie
Dresden
Status unknownDermatologie
Essen
Status unknownUniversitätsklinikum Freiburg
Hugstetter Straße 49, 79106 Freiburg
RecruitingUniversitätsmedizin Göttingen
Robert-Koch-Str. 40, 37075 Göttingen
Recruiting
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.


