Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
10 participants
OBSERVATIONAL
2023-06-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Gorlin syndrome
Children aged six to seventeen years old with Gorlin syndrome and nevoid basal cell carcinomas.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 received topical treatment (imiquimod, 5-fluorouracil, photodynamic therapy and/or cryotherapy) of nevoid basal cell carcinomas during the last three months
6 Years
17 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Kristin Halvorsen Hortemo
Associate Professor, Medical Doctor
Principal Investigators
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Kristin Hortemo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Other Identifiers
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487620
Identifier Type: -
Identifier Source: org_study_id
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