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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Collection of Human Body Material and Clinical Data

    Other intervention

    Blood sampling (serum, plasma, DNA) Tissue sampling (additional biopsy if consented) Completion of Cancer Worry Scale questionnaire

Treatment groups

7,500 Participants
are divided into 1 treatment group
Group A: Biobank Collection Arm1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.