Skin CancerEUNETNCT01385943
VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine
An observational study of Skin Cancer and Skin Lesions, run by Lucid, Inc. at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Skin Lesions
- How many people
- 0 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2011to 1 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain4 sites
Department of Dermatology, Hospital del Mar
Barcelona, 08003
Diagnosis Dermatologica
Barcelona, 08015
Hospital Clinic of Barcelona
Barcelona, 08036
Hospital Ramón y Cajal
Madrid, 28049
Italy2 sites
University of Modena and Reggio Emilia
Modena, 42100
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100
About this study
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.
Read the 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.
- Conditions
- Skin Cancer, Skin Lesions
- Keywords
- Reflectance Confocal Microscopy, Dermoscopy, Clinical Photos, Telemedicine
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Skin Cancer | Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startApr 2011
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Why it stopped: Study not launched due to logistical issues that could not be resolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucid, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona, Hospital Universitario Ramon y Cajal, Hospital del Mar, University of Modena and Reggio Emilia, Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Sponsor
- Investigators
- Josep Malvehy, MD, Principal investigator, Hospital Clinic of Barcelona, SpainGiovanni Pellacani, MD, Principal investigator, Policlinico Hospitale in Modena, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385943
- Sponsor's protocol ID
- 2009/4714
- Acronym
- EUNET
- Status last verified
- Nov 2019
- First submitted
- 28 Jun 2011
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VivaNet Study. A Multicenter Study of Confocal Reflectance Microscopy in Telemedicine
- ClinicalTrials.gov ID
- NCT01385943
- Acronym / sponsor ID
- EUNET / 2009/4714
- Conditions
- Skin Cancer, Skin Lesions
- Keywords
- Reflectance Confocal Microscopy, Dermoscopy, Clinical Photos, Telemedicine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not launched due to logistical issues that could not be resolved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lucid, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Clinic of Barcelona, Hospital Universitario Ramon y Cajal, Hospital del Mar, University of Modena and Reggio Emilia, Azienda USL Reggio Emilia - IRCCS
- Study start
- Apr 2011
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Cancer | – | –Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Malvehy, MD principal investigator
Hospital Clinic of Barcelona, Spain
Giovanni Pellacani, MD principal investigator
Policlinico Hospitale in Modena, Italy
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Skin Lesions, run by Lucid, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.