A Study to Evaluate the DermaSensor Tool on Skin Lesions Suggestive of Skin Cancer
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 20-011463
Sponsor Protocol Number: CSP-18-00002
About this study
The objective of this study is to investigate the sensitivity and specificity of the DermaSensor device in evaluating skin lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma, and to compare the sensitivity of DermaSensor to that of dermatopathology and primary care physicians' empiric diagnosis.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Men or women of any ethnic group aged 22 and older.
- Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy.
- Patient is willing and able to read, understand and sign the ICF.
- Lesion < 2.5mm in diameter or > 15mm in diameter.Lesion surface not accessible (e.g., inside ears, under nails, completely covered by a crust or scale)
- Lesion on area of crust, psoriasis, eczema or similar skin condition.
- Lesion has erosion and/or ulceration with no area > 2.5mm intact.
- Lesion has foreign matter (e.g., tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions).
- Lesion in which the device tip cannot be placed entirely within the border of the targeted area.
- Lesion located on acral skin (e.g., sole or palms).
- Lesion located within 1 cm of the eye.
- Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
- Lesion located on mucosal surfaces (e.g., genitals, lips).
- Lesion located on acute sunburn.
- Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy.
- Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Stephen Merry, M.D.
Closed for enrollment
Alicia Meek BAS
Publications are currently not available