VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine (EUNET)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Hospital Universitario Ramon y Cajal
Hospital del Mar
University of Modena and Reggio Emilia
Arcispedale Santa Maria Nuova-IRCCS
Information provided by (Responsible Party):
Lucid, Inc.
ClinicalTrials.gov Identifier:
NCT01385943
First received: June 28, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition
Skin Cancer
Skin Lesions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine

Resource links provided by NLM:


Further study details as provided by Lucid, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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

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


Estimated Enrollment: 500
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Skin Cancer
Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis.

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

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385943

Locations
Italy
University of Modena and Reggio Emilia
Modena, Italy, 42100
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42100
Spain
Department of Dermatology, Hospital del Mar
Barcelona, Spain, 08003
Diagnosis Dermatologica
Barcelona, Spain, 08015
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Hospital Ramón y Cajal
Madrid, Spain, 28049
Sponsors and Collaborators
Lucid, Inc.
Hospital Clinic of Barcelona
Hospital Universitario Ramon y Cajal
Hospital del Mar
University of Modena and Reggio Emilia
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Principal Investigator: Josep Malvehy, MD Hospital Clinic of Barcelona, Spain
Principal Investigator: Giovanni Pellacani, MD Policlinico Hospitale in Modena, Italy
  More Information

No publications provided

Responsible Party: Lucid, Inc.
ClinicalTrials.gov Identifier: NCT01385943     History of Changes
Other Study ID Numbers: 2009/4714
Study First Received: June 28, 2011
Last Updated: September 27, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Lucid, Inc.:
Reflectance Confocal Microscopy
Dermoscopy
Clinical Photos
Telemedicine

ClinicalTrials.gov processed this record on October 21, 2014