Non-melanoma Skin Cancer Clinical Trial
Official title:
Effectiveness of an Image Analysing Algorithm (DERM) to Diagnose Non-melanoma Skin Cancer (NMSC) and Benign Skin Lesions Compared to Gold Standard Clinical and Histological Diagnosis
NCT number | NCT04116983 |
Other study ID # | DERM-003 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 26, 2020 |
Est. completion date | March 16, 2022 |
Verified date | May 2022 |
Source | Skin Analytics Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign conditions, when used to analyse images of skin lesions taken by commonly available smart phone cameras.
Status | Completed |
Enrollment | 572 |
Est. completion date | March 16, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participant is willing and able to give informed consent for participation in the study, - Male or Female, aged 18 years or above, - Have at least suspicious skin lesion which is suitable for photographing (<15mm, not located on an anatomical site inappropriate to photograph (genitalia, hair-bearing areas, under nails), not previously biopsied, not located in an area of visible scarring or tattooing), - In the Investigator's opinion, able and willing to comply with all study requirements. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Free London NHS Foundation Trust | London | |
United Kingdom | Royal Victoria Infirmary | Newcastle Upon Tyne | |
United Kingdom | Poole General Hospital | Poole |
Lead Sponsor | Collaborator |
---|---|
Skin Analytics Limited | Innovate UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Impact of patient characteristics on the DERM and clinician assessment | The impact of patient characteristics (such as sex, age, location of lesion, total body lesion count, Fitzpatrick skin type, past medical history of skin cancer) on the diagnostic accuracy of DERM and clinician assessment; | Study completion: on average 2 days | |
Other | Impact of lesion characteristics on the DERM and clinician assessment | The impact of lesions characteristic (such as growth over last 6 months, stage and sub-type) on the diagnostic accuracy of DERM and clinician assessment | Study completion: on average 2 days | |
Other | The impact of image variables on the diagnostic accuracy of DERM assessment | The impact of image variables (such as macro and dermoscopic images) on the diagnostic accuracy of DERM assessment | Study completion: on average 2 days | |
Other | DERM performance (AUROC) when macro images are used both to train the algorithm and as test images | Exploration of whether macro images can be used as part of DERM's assessment | Study completion: on average 2 days | |
Primary | AUROC of DERM performance when analysing images of biopsied lesions | Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using histopathological-confirmed diagnosis as gold standard | Study completion | |
Secondary | AUROC of DERM performance when analysing images of non-biopsied lesions | Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using clinical diagnosis as gold standard | Study completion: on average 2 days | |
Secondary | The sensitivity of DERM when used to assess biopsied lesions | The sensitivity of DERM when used to assess biopsied lesions | Study completion: on average 2 days | |
Secondary | The specificity of DERM when used to assess biopsied lesions | The specificity of DERM when used to assess biopsied lesions | Study completion: on average 2 days | |
Secondary | The false positive rate of DERM when used to assess biopsied lesions | The false positive rate of DERM when used to assess biopsied lesions | Study completion: on average 2 days | |
Secondary | The false negative rate of DERM when used to assess biopsied lesions | The false negative rate of DERM when used to assess biopsied lesions | Study completion: on average 2 days | |
Secondary | The positive predictive value of DERM when used to assess biopsied lesions | The positive predictive value of DERM when used to assess biopsied lesions | Study completion: on average 2 days | |
Secondary | The negative predictive value of DERM when used to assess biopsied lesions | The negative predictive value of DERM when used to assess biopsied lesions | Study completion: on average 2 days | |
Secondary | The sensitivity of DERM when used to assess non-biopsied lesions | The sensitivity of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | |
Secondary | The specificity of DERM when used to assess non-biopsied lesions | The specificity of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | |
Secondary | The false positive rate of DERM when used to assess non-biopsied lesions | The false positive rate of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | |
Secondary | The false negative rate of DERM when used to assess non-biopsied lesions | The false negative rate of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | |
Secondary | The positive predictive value of DERM when used to assess non-biopsied lesions | The positive predictive value of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | |
Secondary | The negative predictive value of DERM when used to assess non-biopsied lesions | The negative predictive value of DERM when used to assess non-biopsied lesions | Study completion: on average 2 days | |
Secondary | Concordance of clinician assessment with histologically confirmed diagnosis | Concordance of clinician assessment with histologically confirmed diagnosis | Study completion: on average 2 days | |
Secondary | The concordance of DERM result generated using images from each camera | The concordance of DERM result generated using images from each camera | Study completion: on average 2 days | |
Secondary | The proportion of skin lesions with 3 images that can be analysed by DERM; | The proportion of skin lesions with 3 images that can be analysed by DERM; | Study completion: on average 2 days | |
Secondary | The proportion of skin lesions with at least 1 readable image that can be analysed by DERM | The proportion of skin lesions with at least 1 readable image that can be analysed by DERM | Study completion: on average 2 days |
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