An observational study in Basal Cell Carcinoma and Gorlin Syndrome, sponsored by Oslo University Hospital. Enrolling by invitation at 1 site in Norway. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-06-12.
Sponsored by Oslo University Hospital · 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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 10 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged six to seventeen years with Gorlin syndrome and nevoid basal cell carcinomas living in Norway.
Exclusion Criteria:
Children aged six to seventeen years old with Gorlin syndrome and nevoid basal cell carcinomas.
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.
Nevoid basal cell carcinoma size increase
Largest diameter (measured in millimeter) of nevoid basal cell carcinomas after two years surveillance compared to at baseline.
Time frame: Two years
Dermatoscopy findings
Dermatoscopy findings of nevoid basal cell carcinomas compared to nevoid basal cell carcinoma size increase.
Time frame: Two years
Nevoid basal cell carcinoma histology
Histological analysis, including immune histochemistry, of skin biopsies obtained from representative nevoid basal cell carcinomas.
Time frame: Two years
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.
Time frame: Two years
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.
Time frame: Two years
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Oslo University Hospital