Basal Cell CarcinomaNCT05898347
Nevoid Basal Cell Carcinomas in Gorlin Syndrome
An observational study of Basal Cell Carcinoma and Gorlin Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The overall aim of the project is to gain knowledge about the expected course of nevoid basal cell carcinomas and the usefulness of dermatoscopy in young individuals with Gorlin syndrome. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Basal Cell Carcinoma, Gorlin Syndrome
- What is being tested?
- Active surveillance
- How many people
- 7 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2023to 3 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged six to seventeen years with Gorlin syndrome and nevoid basal cell carcinomas living in Norway.
Who may be able to join
- The individual has Gorlin syndrome (clinically and/or genetically diagnosed)
- The individual is minimum 6 years and maximum 17 years
- The individual has at least three skin lesions clinically compatible with nevoid basal cell carcinomas
Who cannot join
- The patient has a psychiatric disorder not compatible with completion of the study examinations
- The patient has received topical treatment (imiquimod, 5-fluorouracil, photodynamic therapy and/or cryotherapy) of nevoid basal cell carcinomas during the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nevoid Basal Cell Carcinomas in Young People With Gorlin Syndrome
The overall aim of the project is to gain knowledge about the expected course of nevoid basal cell carcinomas and the usefulness of dermatoscopy in young individuals with Gorlin syndrome.
Clinical experience and some case-reports suggest that nevoid basal cell carcinomas have an indolent course with slow growth and that they can sometimes regress. However, no systematic research has previously been performed.
Increased knowledge about nevoid basal cell carcinomas and the use of dermatoscopy could be of great clinical value in the follow-up and treatment of individuals with nevoid basal cell carcinoma syndrome.
- Conditions
- Basal Cell Carcinoma, Gorlin Syndrome
- Being tested
- Active surveillance
- Keywords
- Dermatoscopy
- Medical subject headings
- Carcinoma, Basal Cell, Basal Cell Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceOther
Skin lesions clinically compatible with nevoid basal cell carcinomas are documented with measurements, clinical description, clinical photos and dermatoscopy photos every eight months for two years. Three representative skin lesions are selected at the first visit to be removed by skin biopsy at the end of the observation period (two years) for histopathological analyses.
If a nevoid basal cell carcinoma shows a certain increases in size (according to pre-specified criteria of the study protocol), ulcerates, gets unevenly demarcated or give functional complaints during the observation period, the skin lesion will be excised.
| Study group | Role | What they receive |
|---|---|---|
| Gorlin syndrome | Children aged six to seventeen years old with Gorlin syndrome and nevoid basal cell carcinomas. Receives: Other: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nevoid basal cell carcinoma size increase
Largest diameter (measured in millimeter) of nevoid basal cell carcinomas after two years surveillance compared to at baseline.
Measured: Two years
Dermatoscopy findings
Dermatoscopy findings of nevoid basal cell carcinomas compared to nevoid basal cell carcinoma size increase.
Measured: Two years
Secondary outcomes (1)
Nevoid basal cell carcinoma histology
Histological analysis, including immune histochemistry, of skin biopsies obtained from representative nevoid basal cell carcinomas.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023
- Primary completion20 Jun 2025
- Study completion3 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Halvorsen Hortemo, Oslo University Hospital
- Investigators
- Kristin Hortemo, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898347
- Sponsor's protocol ID
- 487620
- Status last verified
- Oct 2026
- First submitted
- 29 May 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nevoid Basal Cell Carcinomas in Young People With Gorlin Syndrome
- ClinicalTrials.gov ID
- NCT05898347
- Acronym / sponsor ID
- 487620
- Conditions
- Basal Cell Carcinoma, Gorlin Syndrome
- Keywords
- Dermatoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 12 Jun 2023 (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 overall aim of the project is to gain knowledge about the expected course of nevoid basal cell carcinomas and the usefulness of dermatoscopy in young individuals with Gorlin syndrome.
Clinical experience and some case-reports suggest that nevoid basal cell carcinomas have an indolent course with slow growth and that they can sometimes regress. However, no systematic research has previously been performed.
Increased knowledge about nevoid basal cell carcinomas and the use of dermatoscopy could be of great clinical value in the follow-up and treatment of individuals with nevoid basal cell carcinoma syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gorlin syndrome | – | Other: Active surveillanceChildren aged six to seventeen years old with Gorlin syndrome and nevoid basal cell carcinomas. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged six to seventeen years with Gorlin syndrome and nevoid basal cell carcinomas living in Norway.
Key inclusion criteria (3 listed)
- The individual has Gorlin syndrome (clinically and/or genetically diagnosed)
- The individual is minimum 6 years and maximum 17 years
- The individual has at least three skin lesions clinically compatible with nevoid basal cell carcinomas
Key exclusion criteria (2 listed)
- The patient has a psychiatric disorder not compatible with completion of the study examinations
- The patient has received topical treatment (imiquimod, 5-fluorouracil, photodynamic therapy and/or cryotherapy) of nevoid basal cell carcinomas during the last three months
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 |
|---|---|---|
| Active surveillanceSkin lesions clinically compatible with nevoid basal cell carcinomas are documented with measurements, clinical description, clinical photos and dermatoscopy photos every eight months for two years. Three representative skin lesions are selected at the first visit to be removed by skin biopsy at the end of the observation period (two years) for histopathological analyses. If a nevoid basal cell carcinoma shows a certain increases in size (according to pre-specified criteria of the study protocol), ulcerates, gets unevenly demarcated or give functional complaints during the observation period, the skin lesion will be excised. | Other | Gorlin syndrome |
Primary outcome
Nevoid basal cell carcinoma size increase
Time frame: Two years
Largest diameter (measured in millimeter) of nevoid basal cell carcinomas after two years surveillance compared to at baseline.
Dermatoscopy findings
Time frame: Two years
Dermatoscopy findings of nevoid basal cell carcinomas compared to nevoid basal cell carcinoma size increase.
1 secondary outcome
Nevoid basal cell carcinoma histology
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Related trials for Basal Cell Carcinoma
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruiting
Plasmonic PhotoThermal Therapy (PPTT) With Glucose-Coated Gold Nanoparticles (TSK-001) in Patients With Nodular Basal Cell Carcinoma (nBCC)
Nodular BCC
RecruitingObservational study
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT)
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 2
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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. This study is not recruiting at the moment.
Kristin Hortemo, MD, PhD principal investigator
Oslo University Hospital
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 Basal Cell Carcinoma and Gorlin Syndrome, run by Oslo University Hospital at 1 site in Norway.
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 3 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: finished, as of the sponsor's last update on 9 Oct 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nevoid basal cell carcinoma size increase (time frame: Two years). The study lists 2 primary outcomes in all. 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 9 Oct 2026.