Melanoma (Skin) Clinical Trial
— DermaSenseOfficial title:
Comparative Study of Electrical Impedance Spectroscopy (EIS) Models Against Verified Dermatological Diagnostic Data
NCT number | NCT04688749 |
Other study ID # | 489 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | July 17, 2019 |
Est. completion date | December 31, 2022 |
Verified date | July 2023 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Terminated |
Enrollment | 50 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Laboratory of Medical Physics, AUTH | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of Dermasense measurements | Use of DermaSense prototype EIS scanner in detecting significant electrical impedance differences between malignant and benign skin lesions. | 2 weeks | |
Primary | 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 | 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 |
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