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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05898347
Other study ID # 487620
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2025

Study information

Verified date June 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10
Est. completion date December 31, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Other:
Active surveillance
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.

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Clinical manifestations associated with nevoid basal cell carcinomas Presence of congenital anomalities and benign neoplasias (odontogenic keratocysts, other cysts, fibromas) in patients with nevoid basal cell carcinomas. Two years
Other Mutation burden in nevoid basal cell carcinomas analyzed by next-generation sequencing Next-generation sequencing of DNA extracted from skin biopsies obtained from representative nevoid basal cell carcinomas, including genes described in skin carcinomas. Two years
Primary Nevoid basal cell carcinoma size increase Largest diameter (measured in millimeter) of nevoid basal cell carcinomas after two years surveillance compared to at baseline. Two years
Primary Dermatoscopy findings Dermatoscopy findings of nevoid basal cell carcinomas compared to nevoid basal cell carcinoma size increase. Two years
Secondary Nevoid basal cell carcinoma histology Histological analysis, including immune histochemistry, of skin biopsies obtained from representative nevoid basal cell carcinomas. Two years
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