A Study to Evaluate the DermaSensor Tool on Skin Lesions Suggestive of Skin Cancer

Overview

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.

Participation eligibility

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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Merry, M.D.

Closed for enrollment

Contact information:

Alicia Meek BAS

(507) 293-7892

RSTFMSC@mayo.edu

More information

Publications

Publications are currently not available
.

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