Clinical trial · Observational
VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine
NCT01385943CI-TRIAL-00041545EUNETwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study not launched due to logistical issues that could not be resolved.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Lesions | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Skin Cancer
- description
- Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis.
Primary outcomes (1)
- 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.
- description
- 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 outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.