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Confocal Microscopy of Benign and Malignant Skin Tumors

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01010321
First received: November 2, 2009
Last updated: June 27, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention
Skin Cancer
 Device: confocal microscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Confocal Microscopy of Benign and Malignant Skin Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • efficacy of a confocal microscope as a diagnostic tool [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all study Population
all
 Device: confocal microscopy
non-invasive imaging

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men and women over the age of 18

- Skin lesion suspected to either BCC,SCC etc

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant women
  • Children
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010321

Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Aviv Barzilai, Dr. Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Aviv Barzilai, Sheba Medical Cener, Dermatology Unit
ClinicalTrials.gov Identifier: NCT01010321     History of Changes
Other Study ID Numbers: SHEBA-09-7295-AB-CTIL
Study First Received: November 2, 2009
Last Updated: June 27, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
skin lesion suspect as BCC or SCC or others

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013