NCT01010321

Brief Summary

The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.

Trial Health

20
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2009

Shorter than P25 for all trials

Status
suspended

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

November 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

November 2, 2009

Last Update Submit

June 27, 2010

Conditions

Skin Cancer

Keywords

skin lesion suspect as BCC or SCC or others

Outcome Measures

Primary Outcomes (1)

  • efficacy of a confocal microscope as a diagnostic tool

    1 year

Study Arms (1)

all study Population

all

Device: confocal microscopy

Interventions

confocal microscopyDEVICE

non-invasive imaging

all study Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women over the age of 18 \- Skin lesion suspected to either BCC,SCC etc

You may qualify if:

  • Men and women over the age of 18
  • Skin lesion suspected to either BCC or SCC etc
  • Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician

You may not qualify if:

  • Pregnant women
  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Aviv Barzilai, Dr.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 10, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 29, 2010

Record last verified: 2010-06