Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin
Immunohistochemical Analysis of Melanocytes in Sun-Exposed Skin
1 other identifier
observational
100
0 countries
N/A
Brief Summary
The purpose of this study is to estimate and define the mean number, degree of confluence, and depth of penetration of melanocytes in chronically sun exposed skin of the head and neck using Mart-1 immunostains on frozen sections. The study was conducted to confirm whether similar results were found using permanent sections. The present study used hematoxaline and eosin (H\&E) staining as well as Mart-1 staining, and included patients from both Mayo Clinic Jacksonville and Rochester.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2007
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedMarch 15, 2011
March 1, 2011
3 months
April 2, 2009
March 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mean number of melanocytes per high power field for Mart-1 was 12.7 in FL and 11.2 in MN. Using H&E, the means were 10.3 and 8.3 for FL and MN respectively.
one year
Secondary Outcomes (1)
Evidence of higher means in FL than in MN after adjusting for age and gender (p<0.001 for H&E, p=0.08 for Mart-1) and strong evidence of an increase in observed numbers of melanocytes with use of the Mart-1 stain compared to the H&E stain (p<0.001)
one year
Eligibility Criteria
A total of 50 patients from Mayo Clinic Jacksonville and 50 Mayo Clinic Rochester will be enrolled in this study.
You may qualify if:
- Participants undergoing Mohs and reconstructive surgery for basal cell and squamous cell carcinoma of the face and neck
You may not qualify if:
- Participants with a history of radiation to the head and neck were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Biospecimen
The proposed dog-ears excised, that were to be discarded during reconstruction, were evaluated for the presence of any visible lesions (i.e. ephelid, lentigo, seborrheic keratosis, nevi). Dog-ears with any skin lesions were excluded. The specimens were inked by the surgeon on the side to be cut by the histotechnician. The specimens were placed in formalin bottles and submitted to the pathology department at Mayo Clinic Rochester for processing. The tissue was cut (4 microns) along its long access and stained with routine H\& E and Mart-1 (MelanA) immunostains.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence E Gibson, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
September 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 15, 2011
Record last verified: 2011-03