NCT00487864

Brief Summary

In vivo confocal laser scanning microscopy (CLSM) offers the possibility to non-invasively investigate skin lesions at nearly histologic resolution. A recent study showed a high sensitivity (97.6%) and specificity (88.15%) for the discrimination of clinical clear cut melanocytic lesions. CSLM provides horizontal images and can be seen as missing link between dermoscopy and histopathology. For a more accurate diagnosis of dermoscopically difficult to diagnose melanocytic skin lesions in the grey zone between nevus and melanoma, the knowledge of CLSM features of benign nevi seems to be essential. We investigated 30 flat benign nevi with different dermoscopic patterns (10 reticular, 10 globular, 10 homogeneous) nevi. CLSM images were assessed in terms of cytomorphologic and architectural criteria. Different dermoscopic patterns of benign nevi are reflected in different architectural features in CLSM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2007

Completed
Last Updated

June 19, 2007

Status Verified

June 1, 2007

First QC Date

June 18, 2007

Last Update Submit

June 18, 2007

Conditions

Nevus

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of a benign, flat, dermoscopically uniform pigmented nevus.

You may not qualify if:

  • Absence of a benign, flat, dermoscopically uniform pigmented nevus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology and Venerology, University Hospital Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Nevus

Condition Hierarchy (Ancestors)

Nevi and MelanomasNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Rainer Hofmann-Wellenhof, Prof.

    Department of Dermatology, Medical University Graz, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 19, 2007

Study Start

September 1, 2006

Study Completion

May 1, 2007

Last Updated

June 19, 2007

Record last verified: 2007-06

Locations

AU(1)