A Phase 3 interventional study of Clinical decision support tool in Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin and Melanoma in Situ, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Diagnostic
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.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's planned enrollment of 14,000 is above the median of 38 across 2,400 interventional studies indexed under Melanoma.
Browse Melanoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ii. iii. C43 - Malignant melanoma of skin C44 - Other and unspecified malignant neoplasm of skin D03 - Melanoma in situ iv. D04 - Carcinoma in situ of skin v. D18.0 - Hemangioma vi. D22 - Melanocytic nevi vii. D23 - Other benign neoplasms of skin viii. D48.5 - Neoplasm of uncertain behavior of skin ix. D48.9 - - Neoplasm of uncertain behavior, unspecified x. D49.2 - Neoplasm of unspecified behavior of bone, soft tissue, and skin xi. I78.1 - Nevus, non-neoplastic xii. L57 - Skin changes due to chronic exposure to nonionizing radiation xiii. L73.8 - Other specified follicular disorders xiv. L81.4 - Other melanin hyperpigmentation xv. L82 - Seborrheic keratosis xvi. Q82.5 - Congenital non-neoplastic nevus xvii. Z12.83 - Encounter for screening for malignant neoplasm of skin xviii. Z80.8 - Family history of malignant neoplasm of other organs or systems xix. Z85.82 - Personal history of malignant neoplasm of skin xx. Z86.006 - Personal history of melanoma in-situ xxi. Z86.007 - Personal history of in-situ neoplasm of skin
Exclusion Criteria:
Clinical decision support/CDS available to investigative providers; CDS may or may not be used at a given dermatology visit
Diagnostic Test: Clinical decision support tool
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.
Also known as: CDS
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).
Time frame: up to 4 years
Plan to share: Yes — 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.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2029, 36 months after the start.
Of 34 non-industry phase 3 interventional studies under Melanoma, half reached primary completion within 96 months of starting (the median), counting those still running; a quarter within 70 and three quarters within 117. This study's planned 36 months is below that.
Counting every sponsor, half of 97 studies reached it within 47 months; a quarter within 31 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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