Basal Cell Carcinoma Clinical Trial
Official title:
Nevoid Basal Cell Carcinomas in Young People With Gorlin Syndrome
Verified date | June 2023 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
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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