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Pragmatic Randomized Controlled Trial of Artificial Intelligence for Melanoma Diagnosis (PRACTA-MEL) (AI)
Sponsor study identifier
Secondary identifiers
interventional
14,000
1 country
8
Study Start
October 15, 2026
Actual (reported)Primary Completion
October 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to learn whether a computer-based support tool called DEXI (Dermoscopy EXplainable Intelligence) can help dermatologists decide whether a lesion may be melanoma, a serious type of skin cancer. DEXI uses artificial intelligence, or AI, which means computer technology that looks for patterns in images and information. DEXI works within a software program called the DermaGraphix Visualizer, which displays and organizes skin and lesion images. The goal of this study is to see whether DEXI can help doctors find melanoma and reduce biopsies that may not be needed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 16, 2026
Actual (reported)October 22, 2026
Actual (reported)October 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall melanoma detection rate per visit
The primary objective is to evaluate the impact of a clinical decision support tool (CDS) on precision to diagnose melanoma within in-office dermatology visits. Melanoma detection efficiency will be measured (a) total biopsies to rule out melanoma per 100 visits and (b) melanoma diagnosed per 100 visits, compared between visits carried out under standard of care (SOC) versus visits in which the dermatologist (provider) has access to the CDS (enhanced visits).
up to 4 years
Clinical decision support/CDS available to investigative providers; CDS may or may not be used at a given dermatology visit
Clinical decision support/CDS unavailable (technically disabled); Standard of care/SOC skin examination.
Clinical decision support tool (CDS) featuring the DEXI (Dermoscopy EXplainble Intelligence) algorithm within the setting of outpatient dermatology visits at both a dedicated cancer center dermatology service (MSK) and general medical dermatology clinics within a large health network (SU), where melanoma screening or assessment occurs as part of standard care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stanford University (Data Collection Only)
Stanford, California, 94305, United States
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, 07920, United States
Veronica Rotemberg, MD
Memorial Sloan Kettering Cancer Center
First Submitted
October 16, 2026
First Posted
October 22, 2026
Study Start
October 15, 2026
Actual (reported)Primary Completion
October 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, 11553, United States
Study Completion
October 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Source: ClinicalTrials.gov.
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