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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Stephen Merry, M.D.

Cerrado para la inscripción

Contact information:

Alicia Meek BAS

(507) 293-7892

RSTFMSC@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20517097

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