In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588315
First received: December 24, 2007
Last updated: April 26, 2013
Last verified: April 2013
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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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | In Vivo Confocal Microscopy of Cutaneous Neoplasms and Normal Skin |
Resource links provided by NLM:
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 ]
| Estimated Enrollment: | 900 |
| Study Start Date: | November 1999 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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 of the Dermatology and Clinical Immunology Services and Pediatrics that are determined to have a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy will be offered the opportunity to participate in the study.
Criteria
Inclusion Criteria:
- Patients older than or equal to 10 years of age.
- Patients with a skin lesion with anticipated epidermal and superficial dermal histologic alterations amenable to visualization by surface confocal microscopy.
- Healthy volunteer subjects older than or equal to 10 years old.
- Ability to give informed consent.
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 | |
| Contact: Ashfaq Marghoob, MD | 212-610-0780 |
Locations
| United States, New Jersey | |
| Memoral Sloan Kettering Cancer Center | Recruiting |
| Basking Ridge, New Jersey, United States | |
| Contact: Allan Halpern, MD 212-610-0766 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center Hauppauge | Recruiting |
| Hauppauge, New York, United States, 11788 | |
| Contact: Allan Halpern, MD 212-610-0766 | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Allan Halpern, MD 212-610-0766 | |
| Contact: Ashfaq Marghoob, MD 212-610-0780 | |
| 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
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00588315 History of Changes |
| Other Study ID Numbers: | 99-099 |
| Study First Received: | December 24, 2007 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Skin Neoplasms Neoplasms by Site Neoplasms Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013