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NCT Number: NCT07266142

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

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Key information

Conditions

Skin Cancer, Non-Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Cancer Melanoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZLeuven, Department of Dermatology

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Annemiek Leeman, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Sofie Van Kelst, Bsc

CONTACT

[email protected]

0032 016337864

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Establishment of a biobank of human body material (HBM) and clinical data

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

    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

  1. Availability of biobank resources for future research

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Annemiek Leeman, Prof. Dr.

CONTACT

[email protected]

0032 016337950

Sofie Van Kelst, BSc

CONTACT

[email protected]

0032 016337864

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2050
Study completion
2051
First posted
Dec 5, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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