Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin, Melanoma in Situ, Carcinoma in Situ of Skin, Hemangioma, Melanocytic Nevi, Other Benign Neoplasms of Skin, Neoplasm of Uncertain Behavior of Skin, Neoplasm of Uncertain Behavior, Unspecified, Neoplasm of Unspecified Behavior of Bone, Soft Tissue, and Skin, Nevus, Non-Neoplastic, Skin Changes Due to Chronic Exposure to Nonionizing Radiation, Other Specified Follicular Disorders, Other Melanin Hyperpigmentation, Seborrheic Keratosis, Congenital Non-Neoplastic Naevus
Conditions
Keywords
Malignant melanoma of skin, Other and unspecified malignant neoplasm of skin, Melanoma in situ, Carcinoma in situ of skin, Hemangioma, Melanocytic nevi, Other benign neoplasms of skin, Neoplasm of uncertain behavior of skin, Neoplasm of uncertain behavior, unspecified, Neoplasm of unspecified behavior of bone, soft tissue, and skin, Nevus, non-neoplastic, Skin changes due to chronic exposure to nonionizing radiation, Other specified follicular disorders, Other melanin hyperpigmentation, Seborrheic keratosis, Congenital non-neoplastic nevus, Memorial Sloan Kettering Cancer Center, 26-209
Brief summary
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.
Interventions
DIAGNOSTIC_TESTClinical decision support tool
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.
Sponsors
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
Canfield Scientific Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall melanoma detection rate per visit | up to 4 years | 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). |
Countries
United States
Contacts
CONTACTVeronica Rotemberg, MD
CONTACTAshfaq Marghoob, MD
PRINCIPAL_INVESTIGATORVeronica Rotemberg, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed