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FLuorescence Identification of Melanoma by a Multicenter Based Algorithm (FLIMMA)

NCT02425475 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2017-05-03

No results posted yet for this study

Summary

All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histopathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.

Conditions

Interventions

DEVICE

LIMES

All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histo-pathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Claus Garbe, MD · Dept. of Dermatology, University Hospital Tübingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425475 on ClinicalTrials.gov