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The goal of this clinical trial is to set up a prospective, fit-for-purpose collection of human body material (HBM)-blood (serum, plasma, DNA) and tissue-and standardized clinical data of patients with cutaneous melanoma, non-melanoma skin cancer and healthy controls.
The main questions it aims to answer are:
If there is a comparison group: Not applicable (umbrella protocol for collection only).
Participants will:
Share demographics, medical and surgical history, risk factors.
Complete Cancer Worry Scale questionnaire.
Provide biological samples:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biobank Collection Arm | Participants diagnosed with cutaneous melanoma or non-melanoma skin cancer or healthy controls will provide informed consent for collection and long-term storage of human body material (HBM)-blood (serum, plasma, DNA) and tissue-and associated clinical data for future research. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of Human Body Material and Clinical Data | Other | Blood sampling (serum, plasma, DNA) Tissue sampling (additional biopsy if consented) Completion of Cancer Worry Scale questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Establishment of a biobank of human body material (HBM) and clinical data | Successful prospective collection and long-term storage of blood (serum, plasma, DNA), tissue samples, and associated clinical data from patients with cutaneous melanoma, non-melanoma skin cancer and healthy controls. | Baseline (diagnosis and informed consent) through study completion, approximately 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Availability of biobank resources for future research | Number of approved satellite protocols using biobank samples and data for translational research. | Baseline (diagnosis and informed consent) through study completion, approximately 10 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients (≥18 years) diagnosed with cutaneous melanoma or non-melanoma skin cancer (including basal cell carcinoma and squamous cell carcinoma) who are treated at University Hospitals Leuven. Participants must provide voluntary written informed consent prior to any study-related procedures. Patients unable or unwilling to provide consent are excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annemiek Leeman, Prof. Dr. | Contact | 0032 016337950 | annemiek.leeman@uzleuven.be | |
| Sofie Van Kelst, BSc | Contact | 0032 016337864 | sofie.vankelst@kuleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZLeuven, Department of Dermatology | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
Individual participant data (IPD) will not be shared publicly. This study is an umbrella protocol for the collection and long-term storage of human body material (HBM) and associated clinical data in a biobank. Data are pseudonymized and linked to biological samples for future research projects, which require separate ethical approval. Access to IPD will only be granted under strict conditions through approved satellite protocols and in compliance with GDPR and Belgian privacy laws.
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Blood samples (serum, plasma) and tissue samples (tumor and adjacent normal skin).
Samples will be stored long-term in the UZ Leuven Biobank.
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
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