Clinical trial NCT04688749: Use of Electrical Impedance Spectroscopy (EIS) for Early Diagnosis of Skin Damage
Official title: Comparative Study of Electrical Impedance Spectroscopy (EIS) Models Against Verified Dermatological Diagnostic Data
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Dermasense measurements
timeFrame: 2 weeks
measure: Electrical impedance spectroscopy (EIS) measurements
timeFrame: 1 day
Secondary outcomes:
measure: Decision support system
timeFrame: 5 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Medical Physics, AUTH
Study officials:
affiliation: Assistant Professor
name: Emmanouil Papanastasiou, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.