VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to test a protocol that uses clinical pictures, confocal reflectance microscopy images and dermoscopic information in a telemedicine platform. This protocol will test the technologies and diagnostic performance of dermoscopy and confocal reflectance microscopy in a randomized prospective multicenter study in five different centers in Europe.

Detailed Description
-----------------
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.

Official Title
-----------------
VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine

Conditions
-----------------
Skin Cancer, Skin Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any skin tumor considered suspicious for malignancy under clinical non-aided examination Histopathologic study of the tumor or short term follow up (3 months) to confirm benignity Clinical information and images available Adequate imaging by dermoscopy and CRM according to the protocol of the study Consent form signed by the patient Exclusion Criteria: Lesions with ulcerations obscuring more than 75% of the confocal mosaic field of view. Lesions with clinically appreciable scar. Lesions in locations not amenable to imaging with the confocal microscope.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Skin Cancer<br>Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy, in terms of sensitivity, specificity, positive and negative predictive values with respect to histopathologic diagnosis. | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between dermoscopy/confocal microscopy, and dermoscopy plus confocal microscopy | 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. | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reflectance Confocal Microscopy, Dermoscopy, Clinical Photos, Telemedicine