Clinical trial · Interventional
Improving Skin Cancer Management With Artificial Intelligence (04.17 SMARTI)
A Pilot Study of an Artificial Intelligence System as a Diagnostic Aid to Improve Skin Cancer Management (04.17 SMARTI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molemap Skin Cancer Triage Artificial Intelligence Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Lead-in phase
- description
- 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).
- type
- ACTIVE_COMPARATOR
- label
- Active phase
- description
- During the active phase treating clinicians will be given the Molemap artificial intelligence diagnosis in real-time.
- interventionNames
- Device: Molemap Skin Cancer Triage Artificial Intelligence Device
Primary outcomes (1)
- measure
- Diagnostic accuracy of the device when compared prospectively to a teledermatologist assesment
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients attending the specialist dermatology clinics for skin cancer assessment or surveillance. 2. Patients may or may not have a lesion of concern. 3. Patients must have at least two lesions imaged during full skin examination by a dermatologist. 4. Age greater than 18 years. 5. Participant is willing and able to undertake investigation of suspicious lesion (e.g. skin biopsy). Exclusion Criteria: 1. Patient does not give informed consent. 2. Patient is unable or unwilling to have a full skin examination 3. Patient has a known past or current diagnosis of cognitive impairment
References
Publications (1)
- DERIVEDFelmingham 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