Nevoid Basal Cell Carcinomas in Gorlin Syndrome

Trial Title: Nevoid Basal Cell Carcinomas in Gorlin Syndrome

NCT ID: NCT05898347

Condition: Basal Cell Carcinoma
Gorlin Syndrome

Conditions: Official terms:
Carcinoma
Carcinoma, Basal Cell
Basal Cell Nevus Syndrome
Syndrome

Conditions: Keywords:
Dermatoscopy

Study type: Observational

Overall status: Enrolling by invitation

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Active surveillance
Description: 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.
Arm group label: Gorlin syndrome

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.

Criteria for eligibility:

Study pop:
Children aged six to seventeen years with Gorlin syndrome and nevoid basal cell carcinomas living in Norway.

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 6 Years

Maximum age: 17 Years

Healthy volunteers: No

Locations:

Facility:
Name: Oslo University Hospital

Address:
City: Oslo
Zip: 0424
Country: Norway

Start date: June 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Oslo University Hospital
Agency class: Other

Source: Oslo University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05898347