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

NCT07266142 | Recruiting

• 1 other identifier: S70567
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Skin Cancer, Non-Melanoma; Skin Cancer Melanoma

Keywords

Prospective Collection; Skin Cancer; Human Body Material

Outcome Measures

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 and non-melanoma skin cancer.

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

Secondary Outcomes (1)

• Availability of biobank resources for future research

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

Study Arms (1)

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

Interventions

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

Biobank Collection Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects unable or not willing to provide informed consent.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZLeuven, Department of Dermatology

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (serum, plasma) and tissue samples (tumor and adjacent normal skin). Samples will be stored long-term in the UZ Leuven Biobank.

MeSH Terms

Conditions

Skin Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Annemiek Leeman, Prof. Dr.

CONTACT

0032 016337950; annemiek.leeman@uzleuven.be

Sofie Van Kelst, BSc

CONTACT

0032 016337864; sofie.vankelst@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2051
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)