Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin

Completed

• Conditions: Carcinoma, Squamous Cell; Carcinoma, Basal Cell

• Registration Number: NCT00875381
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

For each study participant we recorded their age, sex, state they lived in, tumor type, tumor location, recent sun exposure (during the two weeks prior to the surgery), whether or not a follicle was present on the slide, and if so the follicular extension (mm) from the granular layer, presence of atypia, nesting, pagetoid spread. Two slides were obtained; one stained with Mart-1; the other with H\&E. For both, melanocyte counts per high power field (400 X HPF magnification) were obtained in three locations of the slide. The mean of the 3 counts was used for analysis, though the individual counts were considered in some data summaries (see below). Classification of photo-aging according to the Glogau scale was noted by the surgeon as type1: "no wrinkles"; type II "wrinkles in motion"; type III "wrinkles at rest" and type IV "only wrinkles." Confluence was categorized by the number of adjacent melanocytes as none, mild (2 side-by-side), moderate (3-6), or severe (7 or more).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-14
• Last Update Posted: 2011-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Participants undergoing Mohs and reconstructive surgery for basal cell and squamous cell carcinoma of the face and neck

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Exclusion Criteria

• Participants with a history of radiation to the head and neck were excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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