Clinical trial NCT01385943: VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine
Official title: VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Skin Cancer
Skin Lesions
Keywords: Reflectance Confocal Microscopy
Dermoscopy
Clinical Photos
Telemedicine
Lead sponsor: Lucid
Sponsor class: UNKNOWN
Collaborators: name: Hospital Clinic of Barcelona
name: Hospital Universitario Ramon y Cajal
name: Hospital del Mar
name: University of Modena and Reggio Emilia
name: Azienda USL Reggio Emilia - IRCCS
First posted: 2011-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from private dermatology clinics and university dermatology practices throughout Europe that have a skin lesion suspicious for malignancy under clinical non-aided examination.

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.

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.

Primary outcomes:
measure: Diagnostic accuracy, in terms of sensitivity, specificity, positive and negative predictive values with respect to histopathologic diagnosis.
timeFrame: 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 outcomes:
measure: Differences between dermoscopy/confocal microscopy, and dermoscopy plus confocal microscopy
timeFrame: 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.
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Barcelona
country: Spain
facility: Department of Dermatology, Hospital del Mar
city: Barcelona
country: Spain
facility: Diagnosis Dermatologica
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Hospital Clinic of Barcelona, Spain
name: Josep Malvehy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Hospitale in Modena, Italy
name: Giovanni Pellacani, MD
role: PRINCIPAL_INVESTIGATOR
References: