Prospective Collection of Clinical Data and Human Body Material (HBM) of Cutaneous Melanoma, Non Melanoma Patients and Healthy Controls. Biobank Huidkanker

Universitaire Ziekenhuizen KU Leuven7,500 enrolled

Overview

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: * To create a biobank with samples of human body material (HBM): blood (serum/plasma/DNA) and tissue and clinical data of patients with cutaneous melanoma, non-melanoma and helathy controls. * To support future research questions (after specific approval of the Ethics Committee) by using the biobank (through satellite protocols). 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: * Blood samples (serum, plasma, DNA). * Tissue samples (residual tissue or additional biopsy if consented).

Study Type

OBSERVATIONAL

Enrollment

7,500

Conditions

Skin Cancer, Non-Melanoma Skin Cancer Melanoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures * Adult subjects (\>18 years of age) at time of enrolment. * Subjects diagnosed with cutaneous melanoma, Non-melanoma skin cancer or healthy controls. * Adult subjects able and willing to provide informed consent. Exclusion Criteria: * Subjects unable or not willing to provide informed consent. * Pregnancy (or willing to become pregnant) is NOT an exclusion criteria (unless specified in the respective satellite protocols.

Outcomes

Primary Outcomes

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.

Time frame: Baseline (diagnosis and informed consent) through study completion, approximately 10 years.

Secondary Outcomes

Availability of biobank resources for future research

Number of approved satellite protocols using biobank samples and data for translational research.

Time frame: Baseline (diagnosis and informed consent) through study completion, approximately 10 years.

Central Contacts

Annemiek Leeman, Prof. Dr.

CONTACT

0032 016337950 annemiek.leeman@uzleuven.be

Sofie Van Kelst, BSc