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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014