Nevoid Basal Cell Carcinomas in Gorlin Syndrome

• Conditions: Basal Cell Carcinoma; Gorlin Syndrome
• Interventions: Other: Active surveillance

• Registration Number: NCT05898347
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-29
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gorlin syndrome	Active surveillance	Children aged six to seventeen years old with Gorlin syndrome and nevoid basal cell carcinomas.

Primary Outcome Measures

Name	Time	Method
Nevoid basal cell carcinoma size increase	Two years	Largest diameter (measured in millimeter) of nevoid basal cell carcinomas after two years surveillance compared to at baseline.
Dermatoscopy findings	Two years	Dermatoscopy findings of nevoid basal cell carcinomas compared to nevoid basal cell carcinoma size increase.

Secondary Outcome Measures

Name	Time	Method
Nevoid basal cell carcinoma histology	Two years	Histological analysis, including immune histochemistry, of skin biopsies obtained from representative nevoid basal cell carcinomas.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway