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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a clinical study designed to evaluate if the DermaSense device can be a system of an automated analysis and classification of skin lesions aiming to provide a comprehensive, reliable and cost-effective approach to assist the Dermatologists' decision (biopsy, dermoscopy, histopathological analysis etc). The study enrollment will continue until a minimum of 180 subjects are enrolled in the study. Second Department of Dermatology, School of Medicine, Faculty of Health Sciences of the Aristotle University of Thessaloniki, at the Papageorgiou General Hospital will participate in this study. Dermatologists participating in the study will perform the patient and lesion assessment for biopsy as standard of care at the clinic. EIS (electrical impedance spectroscopy) measurements will be done once per participant recommended by the Dermatologist based on their clinical interest in various areas of the skin. Two sets of measurements will be performed for each participant, either at a nevus in contrast with a nearby clear patch of skin, or at a skin damage area (melanoma, basal cell carcinoma (BCC), squamous cell carcinoma (SCC), etc) in contrast with a nearby clear patch of skin. Also, more repeated measurements may be needed to determine the validity of the measurement result. Evaluation and analysis of the measurement data will be done by the DermaSense team and will be used not only for applying appropriate statistical correlations compared to established dermatological diagnostic methods (eg dermοscopy, histopathological examinations, biopsies etc.) but also for training in artificial intelligence and machine learning methods. Finally, the participants will sign a consent form that is consistent with bioethical rules and according with EU GDPR regulation to protect their personal data.

Official Title
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Comparative Study of Electrical Impedance Spectroscopy (EIS) Models Against Verified Dermatological Diagnostic Data

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

Intervention / Treatment
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* Diagnostic Test: Electrical Impedence Spectroscopy DermaSense


Participation Criteria
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Eligibility Criteria
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The inclusion criteria for patients in this study are as follows: 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. The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated 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 The inclusion criteria for healthy controls in this study are as follows: 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. The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Control<br>Individuals without skin damage (melanoma, BCC, SCC, etc) | Diagnostic Test: Electrical Impedence Spectroscopy DermaSense<br>* 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.<br>|
| Skin lesion<br>Individuals diagnosed with confirmed skin damage by Dermatologists | Diagnostic Test: Electrical Impedence Spectroscopy DermaSense<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision support system | Setting DermaSense prototype EIS scanner in clinical diagnosis of skin lesions, or at least as a potential decision support tool to more accurately identify skin lesions for surgical excision and histopathologic evaluation. | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Melanocytes, Malignancy, Bacal cell carcinoma, Squamous cell carcinoma