About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Collection of Human Body Material and Clinical Data
Other interventionBlood sampling (serum, plasma, DNA) Tissue sampling (additional biopsy if consented) Completion of Cancer Worry Scale questionnaire
Treatment groups
Trial 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.
Secondary outcomes
Availability of biobank resources for future research
Number of approved satellite protocols using biobank samples and data for translational research.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.