Clinical trial NCT06690086: DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer
Official title: DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (DERM-SUCCESS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Keywords: Melanoma
Basal Cell Carcinoma
Squamous Cell Carcinoma
Elastic Scattering Spectroscopy
Lead sponsor: DermaSensor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2024-11-15
Enrollment: 1028
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men or women of any ethnic group aged 22 and older with at least one skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy.

Brief summary: The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.

Detailed description: A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.

Eligibility criteria: Inclusion Criteria:

1. Men or women of any ethnic group aged 22 and older
2. Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy
3. Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. Lesion \< 2.5mm in diameter or \> 15mm in diameter
2. Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
3. Lesion on area of crust, psoriasis, eczema or similar skin condition
4. Lesion has erosion and/or ulceration with no area \>2.5mm intact
5. Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
6. Lesion in which the device tip cannot be placed entirely within the border of the targeted area
7. Lesion located on acral skin (e.g. sole or palms)
8. Lesion located within 1 cm of the eye
9. Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention
10. Lesion located on mucosal surfaces (e.g. genitals, lips)
11. Lesion located on acute sunburn
12. Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy
13. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent

Primary outcomes:
measure: Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
timeFrame: Day 1
measure: Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC
timeFrame: Day 1
Secondary outcomes:
measure: Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%
timeFrame: Day 1
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen P Merry, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: