Symptoms and General Pathology

All Conditions

Neoplasms

Musculoskeletal Diseases

Mouth and Tooth Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Carcinoma

Carcinoma, Basal Cell

Basal Cell Nevus Syndrome

Nevus, Pigmented

Nevus

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Cysts

Odontogenic Cysts

Jaw Cysts

Bone Cysts

Neoplastic Syndromes, Hereditary

Bone Diseases

Bone Diseases, Developmental

Jaw Diseases

Stomatognathic Diseases

Congenital Abnormalities

Abnormalities, Multiple

Genetic Diseases, Inborn

Nevoid Basal Cell Carcinoma Syndrome

Children aged six to seventeen years old with Gorlin syndrome and nevoid basal cell carcinomas.

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.

Active surveillance

Kristin Hortemo, MD, PhD

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.

Nevoid Basal Cell Carcinomas in Gorlin Syndrome

Nevoid Basal Cell Carcinomas in Young People With Gorlin Syndrome

Presence of congenital anomalities and benign neoplasias (odontogenic keratocysts, other cysts, fibromas) in patients with nevoid basal cell carcinomas.

Next-generation sequencing of DNA extracted from skin biopsies obtained from representative nevoid basal cell carcinomas, including genes described in skin carcinomas.

Largest diameter (measured in millimeter) of nevoid basal cell carcinomas after two years surveillance compared to at baseline.

Dermatoscopy findings of nevoid basal cell carcinomas compared to nevoid basal cell carcinoma size increase.

Histological analysis, including immune histochemistry, of skin biopsies obtained from representative nevoid basal cell carcinomas.

Oslo University Hospital

Associate Professor, Medical Doctor

Skin and Connective Tissue Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Participants will be informed of the diagnostic probabilities for each of ten differential diagnoses according to the AI tool

AI assistance

In this study an artificial intelligence (AI) tool for skin cancer diagnosis is implemented in a teleldermatoscopy platform. The aim is to study the effects on clinician diagnostic accuracy, management decisions, and confidence. Furthermore, this prospective randomized study investigates the role of human factors in determining clinician reliance on AI tools and the consequent accuracy in a real-world setting.

Deep-learning algorithms can potentially benefit many areas in healthcare, including the diagnosis of skin cancer using teledermatoscopy. However, there is a dearth of clinical, prospective research on human-AI interaction in diagnostic tasks that take human factors into account.

In this study we will examine the impact of such factors in a real-world setting where we integrate an algorithm in an existing teledermatoscopy platform that is used clinically at a tertiary hospital in Sweden. We will investigate what impact various implementations of AI tool output in relation to human factors have on diagnostic accuracy and management decisions.

Study subjects are recruited at the Department of Dermatology at Karolinska University Hospital and will be asked to rate prospective teledermatoscopic consults with and without AI-support. Each consult will be randomized into one of three workflows with or without one pre-defined implementation of the AI tool. Study subjects are also asked to complete two surveys with demographic information and questions relating to various human factors. Patients participating in the study will be diagnosed outside the study prior to inclusion without any involvement of an AI tool, notably by two experienced dermatologists who do not participate as study subjects.

AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy

AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy: A Prospective Randomized Study

Determine sensitivity, specificity, accuracy and AUROC in terms of diagnostic accuracy for dermatologists with vs without AI advice. Further, to investigate the role of the different workflows (diagnosis with or without AI with varying sequencing) and the influence of demographics and human factors (e.g. level of experience) on diagnostic accuracy

Determine sensitivity, specificity, accuracy and AUROC in terms of accuracy for management decisions for dermatologists with vs without AI and investigate the role of the different workflows (with or without AI with varying sequencing) and the influence of demographics and human factors (e.g. level of experience) on management decisions (biopsy/surgery, no intervention, or follow-up)

Evaluate which factors affect the likelihood of a physician changing their evaluation after receiving algorithmic input

Investigate whether AI or other factors affect the physician's confidence in their diagnosis and management decisions

Karolinska Institutet

Medical University of Vienna

Stockholm School of Economics

Karolinska University Hospital

MD, PhD

Pigmentation Disorders

Use of Nevus doctor program to assess the diagnostic category of pigmented skin lesions

The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.

Nevus doctor program

Thomas R Schopf, Ph.D.

The "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program "Nevus doctor" is better than the performance of the GPs.

In the trial GPs examine patients who attend a primary health care center. A given PSL is first assessed clinically by the GP and afterwards photographed. A clinical photograph as well as a dermatoscopic photograph is taken, the latter using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program. The performance of "Nevus doctor" is compared with the GPs' assessment. A dermatologist reviews all cases based on the clinical and dermatoscopic photographs and this assessment serves as the reference standard.

Nevus Doctor Clinical Decision Support

Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma

Participating GPs are invited to interviews

The computer program tests whether the appearance of a skin lesion is suggestive of skin cancer. There are two possible test outcomes: "suspicious" or "not suspicious". The reference standard is the assessment done by a dermatologist. The number (and percentage) of skin lesions correctly classified as "suspicious" or "not suspicious" is reported. Furthermore sensitivity, specificity, positive and negative predictive values are calculated.

All cases with false test results are described in order to identify any pattern that can help to explain the false test result: correlation with specific types of skin lesions, poor image quality, gender and age of the patients.

University of Tromso

The Research Council of Norway

University Hospital of North Norway

Carcinoma, Squamous Cell

Neoplasms, Squamous Cell

Dermatoscopy not used in decision of surgical margin

Dermatoscopy is used in decision of surgical margin

Dermatoscopy used in decision of surgical margin before resection of basal cell carcinoma or cutaneous squamous cell carcinoma

Dermatoscopy

Fredrik Landström, MD, PhD

Örebro U Hospital

In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.

In basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. In this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. In this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. The outcome measure is radical/non radical resection of the lateral margins. In the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified BCC or cSCC will be included, 200 in each group.

Dermatoscopy Guided Resection for Skin Cancer

Dermatoscopy Guided Resection Margins in Basal Cell Carcinoma and Cutaneos Squamous Cell Carcinoma

If the side margins in the pathology report is radical or not

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nevoid Basal Cell Carcinomas in Gorlin Syndrome	NCT05898347	Basal Cell Carc... Gorlin Syndrome	Active surveill...	6 Years - 17 Years	Oslo University Hospital
AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy	NCT06080711	Skin Cancer Melanoma	AI assistance	18 Years -	Karolinska University Hospital
Nevus Doctor Clinical Decision Support	NCT02012751	Nevus Melanoma	Nevus doctor pr...	18 Years -	University Hospital of North Norway
Dermatoscopy Guided Resection for Skin Cancer	NCT06342297	Basal Cell Carc... Cutaneous Squam... Surgical Margin	Dermatoscopy	18 Years -	Region Örebro County

Spots Global Cancer Trial Database for dermatoscopy

Every month we try and update this database with for dermatoscopy cancer trials from around the world to help patients and their families find trials that might be right for them.
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