An observational study in Melanoma (Skin), Basal Cell Carcinoma and Squamous Cell Carcinoma, sponsored by Aristotle University Of Thessaloniki. Terminated at 1 site in Greece. Open to participants aged 8 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Aristotle University Of Thessaloniki · Observational
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.
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.
24 studies on the registry are indexed under Dysplastic Nevus Syndrome; 7 are open to participants now.
This study's enrollment of 50 is below the median of 283 across 16 observational studies indexed under Dysplastic Nevus Syndrome.
Browse Dysplastic Nevus Syndrome studies →Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.
Compared within Dysplastic Nevus Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Melanoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
The inclusion criteria for patients in this study are as follows:
The inclusion criteria for healthy controls in this study are as follows:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals without skin damage (melanoma, BCC, SCC, etc)
Diagnostic Test: Electrical Impedence Spectroscopy DermaSense
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.
Comparison of Dermasense measurements
Use of DermaSense prototype EIS scanner in detecting significant electrical impedance differences between malignant and benign skin lesions.
Time frame: 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.
Time frame: 1 day
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.
Time frame: 5 months
Ran from Jul 2019 to primary completion in Dec 2022, 41 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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