DERM US and EU Validation Study
A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy
1 other identifier
observational
1,111
2 countries
16
Brief Summary
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Shorter than P25 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2022
CompletedJune 28, 2023
June 1, 2023
5 months
October 18, 2021
June 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of DERM to detect "Malignant conditions"
Sensitivity of DERM to detect Melanoma, SCC and BCC combined
Through study completion, on average of 1 day
Specificity of DERM to detect Malignant conditions.
Specificity of DERM to detect Melanoma, SCC and BCC combined
Through study completion, on average of 1 day
Secondary Outcomes (7)
Sensitivity of DERM to detect Melanoma
Through study completion, on average of 1 day
Specificity of DERM to detect Melanoma
Through study completion, on average of 1 day
Sensitivity of DERM to detect Squamous Cell Carcinoma
Through study completion, on average of 1 day
Specificity of DERM to detect Squamous Cell Carcinoma
Through study completion, on average of 1 day
Sensitivity of DERM to detect Basal Cell Carcinoma
Through study completion, on average of 1 day
- +2 more secondary outcomes
Other Outcomes (10)
Diagnostic accuracy measures
Through study completion, on average of 1 day
Probability that the most probable lesion label DERM returns matches the lesion diagnosis
Through study completion, on average of 1 day
The impact of patient characteristics on the diagnostic accuracy of DERM
Through study completion, on average of 1 day
- +7 more other outcomes
Interventions
An AI-based diagnosis support tool
Eligibility Criteria
Patients attending a dermatology clinic with at least one skin lesion that will be biopsied due to a suspicion of skin cancer will be eligible for the study.
You may qualify if:
- Willing and able to give informed consent for participation in the study,
- Male or Female, aged 18 years or above,
- Have at least one suitable skin lesion that will be biopsied due to a suspicion of skin cancer,
- located on an anatomical site of different skin structure: palms of hands or soles of feet (acral lesion), mucosal surfaces (lips and eyes) or under nail (ungal lesion), a diameter greater than the diameter of the dermoscopic lenses, located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, has been previously biopsied, excised, treated or otherwise traumatised, located in an area of visible scarring or tattooing.
- \- In the Investigator's opinion, able and willing to comply with all study requirements.
You may not qualify if:
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Stanford university
Redwood City, California, 94063, United States
Vista Health Research, LLC
Miami, Florida, 33176, United States
Dorisca Research Consulting, LLC
Miami, Florida, 34761, United States
Northwestern University
Chicago, Illinois, 60208, United States
ALLCUTIS Research, LLC
Beverly, Massachusetts, 01915, United States
Allcutis Research
Methuen, Massachusetts, 01844, United States
Universal Dermatology, PLLC
Fairport, New York, 14450, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Alpesh D. Desai, DO, PLLC, a Houston company institution
Houston, Texas, 34761, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Universitaria Di Bologna
Bologna, Italy
Dermatology University of Florence
Florence, 50100, Italy
Università degli Studi di Modena e Reggio Emilia
Modena, Italy
University of Campania
Napoli, 80131, Italy
Università del Piemonte Orientale
Novara, 28100, Italy
UOSD Dermatology Oncology
Roma, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2021
First Posted
November 18, 2021
Study Start
March 15, 2022
Primary Completion
August 19, 2022
Study Completion
September 15, 2022
Last Updated
June 28, 2023
Record last verified: 2023-06