Pragmatic Randomized Controlled Trial of Artificial Intelligence for Melanoma Diagnosis (PRACTA-MEL) (AI)
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All trials for Malignant Melanoma of Skin All trials for Other and Unspecified Malignant Neoplasm of Skin All trials of Clinical decision support tool
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Investigational Visit | Experimental | Diagnostic Test: Clinical decision support tool | Clinical decision support/CDS available to investigative providers; CDS may or may not be used at a given dermatology visit |
| Control Visit | No intervention | Clinical decision support/CDS unavailable (technically disabled); Standard of care/SOC skin examination. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age 18 years or older at the time of scheduling the office visit. * Presenting for an in-person office visit with an investigative provider at a participating clinical site during the study period. Both referral visits and recurring skin checks are eligible. * Visit must have a mapped ICD-10 code with at least one of the following: 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 * Dermatologist conducting the visit must have undergone training for the how to use and interpret the CDS. Exclusion Criteria: * Telehealth-only, home, inpatient, emergency department, or procedure-only encounters without an in-office visit. * If any image data captured on the patient were known to have been used for training or validating DEXI.
| Facility | City | Country | Status |
|---|---|---|---|
| Stanford University (Data Collection Only) | Stanford, California | United States | Not yet recruiting |
| Memorial Sloan Kettering at Basking Ridge (All protocol activities) | Basking Ridge, New Jersey | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (Consent only) | Middletown, New Jersey | United States | Recruiting |
| Memorial Sloan Kettering Bergen (Consent Only) | Montvale, New Jersey | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) | Commack, New York | United States | Recruiting |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison, New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | New York, New York | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) | Uniondale, New York | United States | Recruiting |
NIH grants: R01CA293974