Clinical trial · Observational
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
Retrospective, Multi-Center Study to Evaluate the Performance of DermDx as an Adjunctive Tool for Primary Care Physicians in the Detection of Skin Cancers
NCT06463860CI-TRIAL-00083937completedClinicalTrials.gov clinicaltrialsProvenance
- 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 proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DermDx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Double reading of all cases with and without software output
- description
- Double reading of all cases with and without software output
- interventionNames
- Device: DermDx
Primary outcomes (2)
- measure
- The change in the diagnostic sensitivity of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
- timeFrame
- 6 months
- description
- The change in the diagnostic sensitivity of the PCPs with the use of DermDx results than without the use of DermDx results in the diagnosis of lesions suspicious of skin cancer, in comparison to the ground truth.
- measure
- The change in the diagnostic accuracy of Primary Care Physicians (PCPs) with and without the use of DermDx in the diagnosis of lesions suspicious of skin cancer
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion criteria: * The subjects must be Primary Care Physicians who are board certified in family medicine or internal medicine. Exclusion criteria: * Subjects not meeting inclusion criteria.
References
Publications (17)
- BACKGROUNDKatragadda C, Finnane A, Soyer HP, Marghoob AA, Halpern A, Malvehy J, Kittler H, Hofmann-Wellenhof R, Da Silva D, Abraham I, Curiel-Lewandrowski C; International Society of Digital Imaging of the Skin (ISDIS)-International Skin Imaging Collaboration (ISIC) Group. Technique Standards for Skin Lesion Imaging: A Delphi Consensus Statement. JAMA Dermatol. 2017 Feb 1;153(2):207-213. doi: 10.1001/jamadermatol.2016.3949. PMID 27892996
- BACKGROUNDRogers HW, Weinstock MA, Harris AR, Hinckley MR, Feldman SR, Fleischer AB, Coldiron BM. Incidence estimate of nonmelanoma skin cancer in the United States, 2006. Arch Dermatol. 2010 Mar;146(3):283-7. doi: 10.1001/archdermatol.2010.19. PMID 20231499
- BACKGROUNDArmstrong BK, Kricker A. The epidemiology of UV induced skin cancer. J Photochem Photobiol B. 2001 Oct;63(1-3):8-18. doi: 10.1016/s1011-1344(01)00198-1. PMID 11684447
- BACKGROUNDLomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x. PMID 22251204
- BACKGROUNDGupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17. PMID 31896400
- BACKGROUNDUS Department of Health and Human Services. The Surgeon General's Call to Action to Prevent Skin Cancer. Washington (DC): Office of the Surgeon General (US); 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK247172/ PMID 25320835
- BACKGROUNDCarlson JA. Tumor doubling time of cutaneous melanoma and its metastasis. Am J Dermatopathol. 2003 Aug;25(4):291-9. doi: 10.1097/00000372-200308000-00003. PMID 12876486