Nevoid Basal Cell Carcinomas in Gorlin Syndrome

Basal Cell Carcinoma Clinical Trial

Official title:

Nevoid Basal Cell Carcinomas in Young People With Gorlin Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05898347
• Other study ID #: 487620
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Basal Cell Nevus Syndrome
• Carcinoma
• Carcinoma, Basal Cell
• Gorlin Syndrome
• Syndrome

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