Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer
Objectives: To evaluate the performance of noninvasive, elastic scattering spectroscopy, algorithm-powered device (DermaSensor) to detect melanoma and basal and squamous cell cancers in the primary care setting. Patients & Methods: DERM-SUCCESS, a blinded, prospective, multicenter pivotal study,...
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2025-06-01
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| Series: | Journal of Primary Care & Community Health |
| Online Access: | https://doi.org/10.1177/21501319251344423 |
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| author | Stephen P. Merry Ivana T. Croghan Kimberly A. Dukes Brian C. McCormick Gerard T. Considine Michelle J. Duvall Curtis T. Thompson David J. Leffell |
| author_facet | Stephen P. Merry Ivana T. Croghan Kimberly A. Dukes Brian C. McCormick Gerard T. Considine Michelle J. Duvall Curtis T. Thompson David J. Leffell |
| author_sort | Stephen P. Merry |
| collection | DOAJ |
| description | Objectives: To evaluate the performance of noninvasive, elastic scattering spectroscopy, algorithm-powered device (DermaSensor) to detect melanoma and basal and squamous cell cancers in the primary care setting. Patients & Methods: DERM-SUCCESS, a blinded, prospective, multicenter pivotal study, enrolled adult patients between August 17, 2020, and December 9, 2021, with lesions that their primary care physicians (PCPs) suspected of skin cancer at clinics in the US (n = 18) and Australia (n = 4). These lesions were assessed by PCPs and scanned with the DermaSensor device. Biopsy specimens were collected, and histopathologic analysis was performed by dermatopathologists. The diagnostic performance of the device, dermatopathologist discordance, and subgroup analyses of clinical interest were calculated. Results: Of the 1579 skin lesions enrolled, dermatopathologic analysis identified 224 (14.2%) cancers. Device sensitivity was 95.5% (95% CI, 91.7%-97.6%) overall and 96.3% (92.9%-98.4%) for patients in the FDA-approved age group 40 years and older (90.2% for melanoma, 97.8% for basal cell carcinoma, and 97.7% for squamous cell carcinoma). Device specificity was 20.7%. The negative predictive value was 96.6%, and the positive predictive value was 16.6% (NNB 6). The device misclassified as “ monitor ” rather than “ investigate further ” 4 keratinocyte carcinomas and 4 melanomas in patients aged 40 years or older (n = 8, 0.5% of lesions, 3.7% of cancers biopsied). Conclusions: The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer adjunctive diagnostic device with high sensitivity and NPV to help inform PCP decision-making about skin lesions suspicious for cancer that need further evaluation and those that may be monitored. |
| format | Article |
| id | doaj-art-ec0e1e5c738d4355bd3decdb9f89cf24 |
| institution | Kabale University |
| issn | 2150-1327 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Journal of Primary Care & Community Health |
| spelling | doaj-art-ec0e1e5c738d4355bd3decdb9f89cf242025-08-20T03:26:38ZengSAGE PublishingJournal of Primary Care & Community Health2150-13272025-06-011610.1177/21501319251344423Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin CancerStephen P. Merry0Ivana T. Croghan1Kimberly A. Dukes2Brian C. McCormick3Gerard T. Considine4Michelle J. Duvall5Curtis T. Thompson6David J. Leffell7Department of Family Medicine, Mayo Clinic, Rochester, MN, USADepartment of Internal Medicine, Division of General Internal Medicine, Mayo Clinic, Rochester, MN, USADepartment of Biostatistics, Boston University School of Public Health, Boston, MA, USAHampton Family Practice, Hampton, VA, USAClare Medical Centre, Clare, SA, AustraliaDepartment of Family Medicine, Mayo Clinic, Rochester, MN, USADepartment of Dermatology and Department of Pathology, Oregon Health & Science University, Portland, Oregon, USA; CTA Pathology: Curtis Thompson, MD & Associates, Beaverton, OR, USADepartment of Dermatology, Section of Dermatologic Surgery and Cutaneous Oncology, Yale School of Medicine, New Haven, CT, USAObjectives: To evaluate the performance of noninvasive, elastic scattering spectroscopy, algorithm-powered device (DermaSensor) to detect melanoma and basal and squamous cell cancers in the primary care setting. Patients & Methods: DERM-SUCCESS, a blinded, prospective, multicenter pivotal study, enrolled adult patients between August 17, 2020, and December 9, 2021, with lesions that their primary care physicians (PCPs) suspected of skin cancer at clinics in the US (n = 18) and Australia (n = 4). These lesions were assessed by PCPs and scanned with the DermaSensor device. Biopsy specimens were collected, and histopathologic analysis was performed by dermatopathologists. The diagnostic performance of the device, dermatopathologist discordance, and subgroup analyses of clinical interest were calculated. Results: Of the 1579 skin lesions enrolled, dermatopathologic analysis identified 224 (14.2%) cancers. Device sensitivity was 95.5% (95% CI, 91.7%-97.6%) overall and 96.3% (92.9%-98.4%) for patients in the FDA-approved age group 40 years and older (90.2% for melanoma, 97.8% for basal cell carcinoma, and 97.7% for squamous cell carcinoma). Device specificity was 20.7%. The negative predictive value was 96.6%, and the positive predictive value was 16.6% (NNB 6). The device misclassified as “ monitor ” rather than “ investigate further ” 4 keratinocyte carcinomas and 4 melanomas in patients aged 40 years or older (n = 8, 0.5% of lesions, 3.7% of cancers biopsied). Conclusions: The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer adjunctive diagnostic device with high sensitivity and NPV to help inform PCP decision-making about skin lesions suspicious for cancer that need further evaluation and those that may be monitored.https://doi.org/10.1177/21501319251344423 |
| spellingShingle | Stephen P. Merry Ivana T. Croghan Kimberly A. Dukes Brian C. McCormick Gerard T. Considine Michelle J. Duvall Curtis T. Thompson David J. Leffell Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer Journal of Primary Care & Community Health |
| title | Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer |
| title_full | Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer |
| title_fullStr | Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer |
| title_full_unstemmed | Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer |
| title_short | Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer |
| title_sort | primary care physician use of elastic scattering spectroscopy on skin lesions suggestive of skin cancer |
| url | https://doi.org/10.1177/21501319251344423 |
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