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In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, November 2008
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00588315
  Purpose

This study investigates new non-invasive imaging techniques for the evaluation of skin lesions, as well as normal skin. Our primary goal is to collect and study these images of different skin lesions along with matching biopsy specimens. The long-term goal is to develop a technique that will improve the early detection of skin cancer and eliminate the need for many skin biopsies.


Condition
Skin Cancer

MedlinePlus related topics: Cancer Skin Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The study is a descriptive one. No formal statistical testing of correlations will be performed. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 750
Study Start Date: November 1999
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
skin lesions
2
normal skin

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients seen at Memorial Sloan-Kettering Cancer Center with a skin lesion or normal skin deemed appropriate for the non-invasive evaluation as part of this study.

Criteria

Inclusion Criteria:

  • Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
  • Healthy volunteer subjects > 18 years old.

Exclusion Criteria:

  • Patients who are allergic to fluorescein sodium.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588315

Contacts
Contact: Allan Halpern, MD 212-610-0766 halperna@mskcc.org
Contact: Susan Krown, MD 212-639-7426 krowns@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Allan Halpern, MD         halperna@mskcc.org    
Contact: Susan Krown, MD         krowns@mskcc.org    
Principal Investigator: Allan Halpern, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Allan Halpern, MD Memorial Sloan-Kettering Cancer Center
  More Information

Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Allan Halpern, MD )
Study ID Numbers: 99-099
Study First Received: December 24, 2007
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00588315  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Skin Diseases
Skin Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009