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Completed

NCT Number: NCT00875381

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

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.

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Key information

Conditions

Carcinoma, Basal Cell Carcinoma Carcinoma, Squamous Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

    Time frame: 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)

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Immunohistochemical Analysis of Melanocytes in Sun-Exposed Skin

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 3, 2009
Registry last updated
Mar 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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