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Study not launched due to logistical issues that could not be resolved.
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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| Hospital Universitario Ramon y Cajal | OTHER |
| Hospital del Mar | OTHER |
| University of Modena and Reggio Emilia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin Cancer | Patients from dermatology practices throughout Europe that have a skin lesion or tumor requiring a biopsy for diagnosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from private dermatology clinics and university dermatology practices throughout Europe that have a skin lesion suspicious for malignancy under clinical non-aided examination.
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| Name | Affiliation | Role |
|---|---|---|
| Josep Malvehy, MD | Hospital Clinic of Barcelona, Spain | Principal Investigator |
| Giovanni Pellacani, MD | Policlinico Hospitale in Modena, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Modena and Reggio Emilia | Modena | 42100 | Italy | |||
| Arcispedale Santa Maria Nuova |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
| Azienda USL Reggio Emilia - IRCCS | OTHER_GOV |
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Cutaneous tissue specimens in the form of histopathology slides and tissue blocks, clinical pictures, dermoscopic pictures and confocal microscopy images
| 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. |
| Reggio Emilia |
| 42100 |
| Italy |
| Department of Dermatology, Hospital del Mar | Barcelona | 08003 | Spain |
| Diagnosis Dermatologica | Barcelona | 08015 | Spain |
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
| Hospital Ramón y Cajal | Madrid | 28049 | Spain |