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

NCT01385943 | Withdrawn

• 1 other identifier: 2009/4714
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 6

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.

Conditions

Skin Cancer; Skin Lesions

Keywords

Reflectance Confocal Microscopy; Dermoscopy; Clinical Photos; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Differences between dermoscopy/confocal microscopy, and dermoscopy plus confocal microscopy

  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.

Study Arms (1)

Skin Cancer

Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lucid, Inc.: lead
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital del Mar: collaborator
• University of Modena and Reggio Emilia: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator

Study Sites (6)

University of Modena and Reggio Emilia

Modena, 42100, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

Department of Dermatology, Hospital del Mar

Barcelona, 08003, Spain

Location

Diagnosis Dermatologica

Barcelona, 08015, Spain

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Hospital Ramón y Cajal

Madrid, 28049, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cutaneous tissue specimens in the form of histopathology slides and tissue blocks, clinical pictures, dermoscopic pictures and confocal microscopy images

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Josep Malvehy, MD

  Hospital Clinic of Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Giovanni Pellacani, MD

  Policlinico Hospitale in Modena, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 30, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

IT (2); ES (4)