Skin Cancer, Non-MelanomaNCT07266142
Prospective Collection of Clinical Data and Human Body Material (HBM) of Cutaneous Melanoma, Non Melanoma Patients and Healthy Controls. Biobank Huidkanker
An observational study of Skin Cancer, Non-Melanoma and Skin Cancer Melanoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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, non-melanoma skin cancer and healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Non-Melanoma, Skin Cancer Melanoma
- What is being tested?
- Collection of Human Body Material and Clinical Data
- How many people
- 7,500 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Nov 2025to Jan 2051
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven, Department of Dermatology
Leuven, Vlaams-Brabant, 3000
Sofie Van Kelst, Bsc, 0032 016337864, sofie.vankelst@kuleuven.be
Annemiek Leeman, Prof. Dr.
About this study
Official 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
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:
Read more
- 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).
- Conditions
- Skin Cancer, Non-Melanoma, Skin Cancer Melanoma
- Being tested
- Collection of Human Body Material and Clinical Data
- Keywords
- Prospective Collection, Skin Cancer, Human Body Material
- Medical subject headings
- Skin Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of Human Body Material and Clinical DataOther
Blood sampling (serum, plasma, DNA) Tissue sampling (additional biopsy if consented) Completion of Cancer Worry Scale questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Biobank Collection Arm | Participants diagnosed with cutaneous melanoma or non-melanoma skin cancer or healthy controls 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. Receives: Other: Collection of Human Body Material and Clinical Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (diagnosis and informed consent) through study completion, approximately 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start17 Nov 2025
- Primary completionJan 2050 (estimated)
- Study completionJan 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer, Non-MelanomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266142
- Sponsor's protocol ID
- S70567
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07266142
- Acronym / sponsor ID
- S70567
- Conditions
- Skin Cancer, Non-Melanoma, Skin Cancer Melanoma
- Keywords
- Prospective Collection, Skin Cancer, Human Body Material
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2051 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biobank Collection Arm | – | Other: Collection of Human Body Material and Clinical DataParticipants diagnosed with cutaneous melanoma or non-melanoma skin cancer or healthy controls 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of Human Body Material and Clinical DataBlood sampling (serum, plasma, DNA) Tissue sampling (additional biopsy if consented) Completion of Cancer Worry Scale questionnaire | Other | Biobank Collection Arm |
Primary outcome
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.
1 secondary outcome
Availability of biobank resources for future research
Time frame: Baseline (diagnosis and informed consent) through study completion, approximately 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, Non-Melanoma and Skin Cancer Melanoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemiek Leeman, Prof. Dr. (0032 016337950, annemiek.leeman@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.