Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

DERM Health Economics Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04123678
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Innovate UK
Information provided by (Responsible Party):
Skin Analytics Limited

Brief Summary:
This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.

Condition or disease Intervention/treatment
Melanoma Non-melanoma Skin Cancer Device: Deep Ensemble for the Recognition of Malignancy (DERM)

Detailed Description:

DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify melanoma, non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles).

This study aims to establish whether the use of DERM in the patient pathway could reduce the number of unnecessary referrals to dermatologist review and/or biopsy.

Suspicious skin lesions that are due to be photographed for a dermatologist to review, will have two additional photographs taken using a commonly available smart phone camera with and without a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-confirmed diagnosis (any lesion that is biopsied).


Layout table for study information
Study Type : Observational
Estimated Enrollment : 581 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of an Artificial Intelligence Platform (DERM) on the Healthcare Resource Utilisation (HRU) Needed to Diagnose Skin Cancer When Used as Part of a United Kingdom-based Teledermatology Service
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Group/Cohort Intervention/treatment
All
Patients attending a Medical Photography facility with at least 1 suspicious skin lesion will be approached to participate in the study. Participants will have an additional macro and dermoscopic image of each suspicious skin lesions suitable for photography. Photographs will be taken by a healthcare professional using an iPhone XR smart phone camera with a DL1 dermoscopic lens attachment. The images will be encrypted and electronically transmitted to Skin Analytics' cloud servers for analysis by DERM. The suspected diagnosis determined by DERM will be compared with dermatologist review and histologically confirmed diagnosis, where obtained. Healthcare resource utilization information and patient satisfaction data will also be collected
Device: Deep Ensemble for the Recognition of Malignancy (DERM)
AI-based decision support tool




Primary Outcome Measures :
  1. Referral rate [ Time Frame: Study completion, on average 5 days ]
    The rate of unnecessary referrals for a face to face dermatologist review for the same detection rate between standard of care and DERM of lesions reviewed by teledermatology or DERM


Secondary Outcome Measures :
  1. Sensitivity of DERM on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Sensitivity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  2. Specificity of DERM on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Specificity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  3. False positive rate of DERM on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    False positive rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  4. False negative rate of DERM on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    False negative rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  5. Positive predictive value of DERM on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Positive predictive value of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  6. Number needed to biopsy by DERM on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Number needed to biopsy by DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  7. Sensitivity of teledermatologists on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Sensitivity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  8. Specificity of teledermatologists on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Specificity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  9. False positive rate of teledermatologists on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    False positive rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  10. False negative rate of teledermatologists on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    False negative rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  11. Positive predictive value of teledermatologists on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Positive predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  12. Negative predictive value of teledermatologists on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Negative predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  13. Number needed to biopsy by teledermatologists on biopsied lesions [ Time Frame: Study completion, on average 5 days ]
    Number needed to biopsy by teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard

  14. Sensitivity of DERM to identify benign conditions [ Time Frame: Study completion, on average 5 days ]
    Sensitivity of DERM to identify benign conditions, using clinical diagnosis as gold-standard

  15. Specificity of DERM to identify benign conditions [ Time Frame: Study completion, on average 5 days ]
    Specificity of DERM to identify benign conditions, using clinical diagnosis as gold-standard

  16. False positive rate of DERM to identify benign conditions [ Time Frame: Study completion, on average 5 days ]
    False positive of DERM to identify benign conditions, using clinical diagnosis as gold-standard

  17. False negative rate of DERM to identify benign conditions [ Time Frame: Study completion, on average 5 days ]
    False negative rate of DERM to identify benign conditions, using clinical diagnosis as gold-standard

  18. Positive predictive value of DERM to identify benign conditions [ Time Frame: Study completion, on average 5 days ]
    Positive predictive of DERM to identify benign conditions, using clinical diagnosis as gold-standard

  19. Negative predictive value of DERM to identify benign conditions [ Time Frame: Study completion, on average 5 days ]
    Negative predictive value of DERM to identify benign conditions, using clinical diagnosis as gold-standard

  20. Number needed to refer by DERM to identify benign conditions [ Time Frame: Study completion, on average 5 days ]
    Number needed to refer by DERM to identify benign conditions, using clinical diagnosis as gold-standard

  21. Concordance of DERM result with clinical diagnosis [ Time Frame: Study completion, on average 5 days ]
    Concordance of DERM result with clinical diagnosis

  22. Percent of patients attending teledermatology by referral route [ Time Frame: Study completion, on average 5 days ]
    Percentage of patients referred to teledermatology through 2-week wait referral, general referral, direct to teledermatology, routine follow-up (etc) referral routes

  23. Time taken from general practitioner (GP) referral to diagnosis [ Time Frame: Study completion, on average 5 days ]
    Time taken (days) from GP referral to either histopathology-confirmed or clinical diagnosis

  24. Estimated cost impact associated with introducing DERM into the patient pathway [ Time Frame: Study completion, on average 5 days ]
    The cost of the number of referrals for face to face dermatologist review and/or biopsy that would have been saved / charged if DERM had been used to decide whether to refer the patient onwards

  25. Proportion of images submitted to DERM that cannot be analysed [ Time Frame: Study completion, on average 5 days ]
    Proportion of images submitted to DERM that cannot be analysed

  26. Patient satisfaction survey [ Time Frame: Study completion, on average 5 days ]
    Patient feedback on their experience of the service. Patients will rate whether they agree, or don't agree, with statements that assess their acceptance of having a computer involved in their diagnosis pathway



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients attending Medical Photography for imaging of at least 1 suspicious skin lesion. Patients may have been referred to the teledermatology service or for imaging for monitoring purposes from the dermatology clinic or for virtual teledermatology review.
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study,
  • Male or Female, aged 18 years or above,
  • Has at least one suspicious skin lesion which is being photographed as part of Standard of Care (SoC),
  • In the Investigators 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 participants 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123678


Contacts
Layout table for location contacts
Contact: Clinical Research Director 020 8064 1967 support@skinanalytics.co.uk

Locations
Layout table for location information
United Kingdom
Chelsea and Westminster Hospital Not yet recruiting
London, United Kingdom, SW10 9NH
Contact: Lucy Thomas    020 3315 8000      
Sponsors and Collaborators
Skin Analytics Limited
Innovate UK

Layout table for additonal information
Responsible Party: Skin Analytics Limited
ClinicalTrials.gov Identifier: NCT04123678     History of Changes
Other Study ID Numbers: DERM-005
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Research to improve or test the performance of DERM only allowed in consent

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Neoplasms
Neoplasms by Site
Skin Diseases