Improving Skin Cancer Management With Artificial Intelligence (04.17 SMARTI)

NCT04040114 | Completed DMC

• 1 other identifier: 04.17
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The study is designed to be able to prove if the Molemap Artificial Intelligence (AI) algorithm can be used as a diagnostic aid in a clinical setting. This study will determine whether the diagnostic accuracy of the Molemap AI algorithm is comparable to a specialist dermatologist, teledermatologist and registrar (as a surrogate for a general practitioner). The study patient population will be adult patients who require skin cancer assessment. The use of AI as a diagnostic aid may assist primary care physicians who have variable skill in skin cancer diagnosis and lead to more appropriate referrals (rapid referral for lesions requiring treatment and fewer referrals for benign lesions), thereby improving access and reducing waiting times for specialist care.

Conditions

Skin Cancer; Melanoma (Skin)

Keywords

Artificial Intelligence; Surveillance; Melanoma; Skin Cancer; photography

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the device when compared prospectively to a teledermatologist assesment

  Sensitivity and specificity of the algorithm compared to the teledermatologist.

  12 months

Secondary Outcomes (4)

• Diagnostic accuracy of the device when used prospectively as compared to a dermatologist assessment

  12 months

• Diagnostic accuracy of the device compared to teledermatologist, dermatologist and registrar using histopathology as 'gold standard' for any lesions biopsied.

  12 months

• Appropriate selection of lesions by registrar compared to specialist dermatologists

  12 months

• Appropriateness of management by registrar compared to specialist dermatologists and impact AI might have on this.

  12 months

Study Arms (2)

Lead-in phase

NO INTERVENTION

During the lead-in phase treating clinicians will not be given the Molemap artificial intelligence diagnosis in real-time (i.e. in clinic with the patient).

Active phase

ACTIVE COMPARATOR

During the active phase treating clinicians will be given the Molemap artificial intelligence diagnosis in real-time.

Device: Molemap Skin Cancer Triage Artificial Intelligence Device

Interventions

Molemap Skin Cancer Triage Artificial Intelligence Device DEVICE

This device/software incorporates artificial intelligence to provide a diagnostic aide for clinicians of patients with potentially malignant skin lesions. The software is supported by the use of cameras for acquisition of images.

Active phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending the specialist dermatology clinics for skin cancer assessment or surveillance.
• Patients may or may not have a lesion of concern.
• Patients must have at least two lesions imaged during full skin examination by a dermatologist.
• Age greater than 18 years.
• Participant is willing and able to undertake investigation of suspicious lesion (e.g. skin biopsy).

You may not qualify if:

• Patient does not give informed consent.
• Patient is unable or unwilling to have a full skin examination
• Patient has a known past or current diagnosis of cognitive impairment

Sponsors & Collaborators

• Melanoma and Skin Cancer Trials Limited: lead
• Monash University: collaborator

Study Sites (2)

The Alfred- Victorian Melanoma Service

Melbourne, Victoria, 3004, Australia

Location

Skin Health Institute

Melbourne, Victoria, 3053, Australia

Location

Related Publications (1)

• Felmingham C, MacNamara S, Cranwell W, Williams N, Wada M, Adler NR, Ge Z, Sharfe A, Bowling A, Haskett M, Wolfe R, Mar V. Improving Skin cancer Management with ARTificial Intelligence (SMARTI): protocol for a preintervention/postintervention trial of an artificial intelligence system used as a diagnostic aid for skin cancer management in a specialist dermatology setting. BMJ Open. 2022 Jan 4;12(1):e050203. doi: 10.1136/bmjopen-2021-050203.

  PMID: 34983756 DERIVED

MeSH Terms

Conditions

Skin Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Study Officials

• Victoria Mar, A/Prof

  Monash University, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Teledermatologist will be blinded to the Artificial Intelligence algorithm diagnosis.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled before-and-after intervention study

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: October 1, 2019
• Primary Completion: May 19, 2021
• Study Completion: May 30, 2021
• Last Updated: August 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)