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

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ClinicalTrials.gov Identifier: NCT04688749
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Emmanouil Papanastasiou, Aristotle University Of Thessaloniki

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.

Condition or disease Intervention/treatment
Melanoma (Skin) Basal Cell Carcinoma Squamous Cell Carcinoma Dysplastic Nevus Syndrome Lentigo Maligna Seborrheic Keratosis Lichen Planus-Like Keratosis Carcinosarcoma Diagnostic Test: Electrical Impedence Spectroscopy DermaSense

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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparative Study of Electrical Impedance Spectroscopy (EIS) Models Against Verified Dermatological Diagnostic Data
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Group/Cohort Intervention/treatment
Healthy Control
Individuals without skin damage (melanoma, BCC, SCC, etc)
Diagnostic Test: Electrical Impedence Spectroscopy DermaSense
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.

Skin lesion
Individuals diagnosed with confirmed skin damage by Dermatologists
Diagnostic Test: Electrical Impedence Spectroscopy DermaSense
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.




Primary Outcome Measures :
  1. Comparison of Dermasense measurements [ Time Frame: 2 weeks ]
    Use of DermaSense prototype EIS scanner in detecting significant electrical impedance differences between malignant and benign skin lesions.

  2. Electrical impedance spectroscopy (EIS) measurements [ Time Frame: 1 day ]
    Use of DermaSense prototype EIS scanner in measuring Electrical Impedance Spectroscopy (EIS) at 10 different frequencies in skin of various body surfaces.


Secondary Outcome Measures :
  1. Decision support system [ Time Frame: 5 months ]
    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.



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Ages Eligible for Study:   8 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688749


Contacts
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Contact: Sotiria Gilou, MSc +306946958582 sotiriagilou@gmail.com
Contact: Panagiotis D Bamidis, Dr. pdbamidis@gmail.com

Locations
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Greece
Laboratory of Medical Physics, AUTH Recruiting
Thessaloniki, Greece
Contact: Panagiotis Bamidis, Dr.    00302310999310    bamidis@auth.gr   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Emmanouil Papanastasiou, Dr. Assistant Professor
Publications:
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Responsible Party: Emmanouil Papanastasiou, Assistant Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04688749    
Other Study ID Numbers: 489
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 30, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emmanouil Papanastasiou, Aristotle University Of Thessaloniki:
Melanoma
Melanocytes
Malignancy
Bacal cell carcinoma
Squamous cell carcinoma
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Squamous Cell
Keratosis, Actinic
Carcinoma, Basal Cell
Carcinosarcoma
Hutchinson's Melanotic Freckle
Dysplastic Nevus Syndrome
Keratosis
Lichen Planus
Lentigo
Keratosis, Seborrheic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Skin Diseases
Precancerous Conditions
Neoplasms, Basal Cell
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Melanosis