VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine (EUNET)
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|ClinicalTrials.gov Identifier: NCT01385943|
Recruitment Status : Unknown
Verified September 2013 by Lucid, Inc..
Recruitment status was: Active, not recruiting
First Posted : June 30, 2011
Last Update Posted : September 30, 2013
|Condition or disease|
|Skin Cancer Skin Lesions|
In vivo confocal reflectance microscopy (CRM) is a non-invasive method for the in vivo (without cutting into the skik) examination of skin tumors. CRM produces cellular images with resolution comparable to histopathology. The procedure is painless, takes about ten minutes and has no documented side effects. Studies performed in the past decade have correlated CRM features in benign (non-cancerous) and malignant (cancerous) skin lesions such as moles and melanomas, as well as features of inflammatory lesions (such as allergic skin reactions) to histopathology.
Dermoscopy is a complementary technique that has been proven to be superior to the naked eye for the diagnosis of melanoma as well as some non-melanocytic skin tumors. Recently, correlation of dermoscopic and CRM structures has focused interest in the research in different groups that show that both are complementary and render in combination a better understanding of skin disease.
In this study, patients from several research centers in Europe, with lesions suspicious for malignancy and scheduled for biopsy will be asked if they would like to participate in the study. If they consent to the study, first, a clinical photograph will be taken of the lesion. Second, a dermoscopic image will be taken of the lesion, and third, CRM images will be taken of the lesion. Finally, the biopsy will be performed as per the standard of care. The images will be sent over a secure, private internet connection to physicians specially trained in the interpretation of dermoscopic and CRM images. An electronic report will be completed and returned to the Study Coordinator, who will correlate the results with the histopathologic diagnosis.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis.
- Diagnostic accuracy, in terms of sensitivity, specificity, positive and negative predictive values with respect to histopathologic diagnosis. [ Time Frame: Study participation will be no longer than three months for patients requiring follow up, and no longer than one office visit (approximately one hour) for patients being biopsied the same day they are imaged. ]Clinical pictures, dermoscopic pictures, confocal images and tissue biopsy will be obtained in a single study visit unless the physician determines that short-term (3 months) follow up is more appropriate, then the patient will be asked to return in three months for additional examination.
- Differences between dermoscopy/confocal microscopy, and dermoscopy plus confocal microscopy [ Time Frame: Study participation will be no longer than three months for patients requiring follow up, and no longer than one office visit (approximately one hour) for patients being biopsied the same day they are imaged. ]Clinical pictures, dermoscopic pictures, confocal images and tissue biopsy will be obtained in a single study visit as described under Primary Outcomes, unless the physician determines that short-term (3 months) follow up is more appropriate, then the patient will be asked to return in three months for additional examination.
Biospecimen Retention: Samples Without DNA
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): NCT01385943
|University of Modena and Reggio Emilia|
|Modena, Italy, 42100|
|Arcispedale Santa Maria Nuova|
|Reggio Emilia, Italy, 42100|
|Department of Dermatology, Hospital del Mar|
|Barcelona, Spain, 08003|
|Barcelona, Spain, 08015|
|Hospital Clinic of Barcelona|
|Barcelona, Spain, 08036|
|Hospital Ramón y Cajal|
|Madrid, Spain, 28049|
|Principal Investigator:||Josep Malvehy, MD||Hospital Clinic of Barcelona, Spain|
|Principal Investigator:||Giovanni Pellacani, MD||Policlinico Hospitale in Modena, Italy|