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

Prospective Collection of Clinical Data and Human Body Material (HBM): Blood (Serum, Plasma, DNA) and Tissue of Cutaneous Melanoma and Non Melanoma Patients. Biobank Huidkanker

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 and non-melanoma skin cancer.

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 and non-melanoma.
• 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 Overview

• Status: Recruiting
• Conditions: Skin Cancer, Non-Melanoma; Skin Cancer Melanoma
• Intervention / Treatment: Other: Collection of Human Body Material and Clinical Data

• Study Type: Observational
• Enrollment (Estimated): 7500

Contacts and Locations

• Study Contact: Name: Annemiek Leeman, Prof. Dr.; Phone Number: 0032 016337950; Email: annemiek.leeman@uzleuven.be
• Study Contact Backup: Name: Sofie Van Kelst, Bsc; Phone Number: 0032 016337864; Email: sofie.vankelst@kuleuven.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZLeuven, Department of Dermatology
      • Contact: Sofie Van Kelst, Bsc; Phone Number: 0032 016337864; Email: sofie.vankelst@kuleuven.be
      • Principal Investigator: Annemiek Leeman, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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 or Non-melanoma skin cancer.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Biobank Collection Arm; Participants diagnosed with cutaneous melanoma or non-melanoma skin cancer 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.	Other: Collection of Human Body Material and Clinical Data; Blood sampling (serum, plasma, DNA) Tissue sampling (additional biopsy if consented) Completion of Cancer Worry Scale questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 and non-melanoma skin cancer.	Baseline (diagnosis and informed consent) through study completion, approximately 10 years.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2051

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Skin Cancer; Prospective Collection; Human Body Material
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin and Connective Tissue Diseases; Melanoma; Skin Neoplasms
• Other Study ID Numbers: S70567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No