Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage

NCT04688749 | Terminated

• 1 other identifier: 489
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate if the DermaSense prototype EIS scanner can provide medical decision support which can complement dermoscopy-based identification of the disease at time of biopsy decision.

Conditions

Melanoma (Skin); Basal Cell Carcinoma; Squamous Cell Carcinoma; Dysplastic Nevus Syndrome; Lentigo Maligna; Seborrheic Keratosis; Lichen Planus-Like Keratosis; Carcinosarcoma

Keywords

Melanoma; Melanocytes; Malignancy; Bacal cell carcinoma; Squamous cell carcinoma

Outcome Measures

Primary Outcomes (2)

• Comparison of Dermasense measurements

  Use of DermaSense prototype EIS scanner in detecting significant electrical impedance differences between malignant and benign skin lesions.

  2 weeks

• Electrical impedance spectroscopy (EIS) measurements

  Use of DermaSense prototype EIS scanner in measuring Electrical Impedance Spectroscopy (EIS) at 10 different frequencies in skin of various body surfaces.

  1 day

Secondary Outcomes (1)

• Decision support system

  5 months

Study Arms (2)

Healthy Control

Individuals without skin damage (melanoma, BCC, SCC, etc)

Diagnostic Test: Electrical Impedence Spectroscopy DermaSense

Skin lesion

Individuals diagnosed with confirmed skin damage by Dermatologists

Diagnostic Test: Electrical Impedence Spectroscopy DermaSense

Interventions

Electrical Impedence Spectroscopy DermaSense DIAGNOSTIC_TEST

Two sets of measurements will be performed to each subject, either at a nevus in contrast with a nearby clear patch of skin. The duration of each measurement will last for approximately 1.5 minutes and the excel file will be directly available to researcher, allowing him/her for data storage and data visualization.

Healthy Control; Skin lesion

Eligibility Criteria

• Age: 8 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Greek citizens aged 8-90 years old, regardless of gender, who are diagnosed by Dermatologists as standard of care at the Second Dermatological Clinic of Papageorgiou General Hospital of Thessaloniki in Greece, which participates in the study.

You may qualify if:

• Male or female at least 8 years old
• Individuals diagnosed with confirmed skin damage by Dermatologists
• Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi), so necessitating a biopsy.
• Participant himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent
• Participants under 18 years old must have a parent, or / and other reliable caregiver who agrees to accompany him/her to the measurements, provide information about the participant as required by the protocol
• Male or female at least 8 years old
• Matched healthy control population: Individuals without skin damage (melanoma, BCC, SCC, etc) that have been included in cohort.
• Lesions that present with unclear clinical presentation to allow for clinical diagnosis of benign or minimally dysplastic nevus (nevi), so necessitating a biopsy.
• Participant himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent
• Participants under 18 years old must have a parent, or / and other reliable caregiver who agrees to accompany him/her to the measurements, provide information about the participant as required by the protocol

You may not qualify if:

• concurrent participation in another relevant study
• occurrence of skin damage during the study
• Subjects who fail to provide informed consent
• Study subjects with underlying medical disease which may alter ability to diagnose clinically or inhibit DermaSense prototype EIS scanner from collecting data

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Laboratory of Medical Physics, AUTH

Thessaloniki, Greece

Location

Related Publications (3)

• Apalla Z, Lallas A, Sotiriou E, Lazaridou E, Ioannides D. Epidemiological trends in skin cancer. Dermatol Pract Concept. 2017 Apr 30;7(2):1-6. doi: 10.5826/dpc.0702a01. eCollection 2017 Apr.

  PMID: 28515985 BACKGROUND

• Mohr P, Birgersson U, Berking C, Henderson C, Trefzer U, Kemeny L, Sunderkotter C, Dirschka T, Motley R, Frohm-Nilsson M, Reinhold U, Loquai C, Braun R, Nyberg F, Paoli J. Electrical impedance spectroscopy as a potential adjunct diagnostic tool for cutaneous melanoma. Skin Res Technol. 2013 May;19(2):75-83. doi: 10.1111/srt.12008. Epub 2013 Jan 27.

  PMID: 23350668 BACKGROUND

• Malvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19.

  PMID: 24841846 BACKGROUND

MeSH Terms

Conditions

Melanoma; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Dysplastic Nevus Syndrome; Hutchinson's Melanotic Freckle; Keratosis, Seborrheic; Carcinosarcoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Neoplasms, Squamous Cell; Nevus; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Neoplasms, Complex and Mixed; Sarcoma; Neoplasms, Connective and Soft Tissue

Study Officials

• Emmanouil Papanastasiou, Dr.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 30, 2020
• Study Start: July 17, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

GR (1)