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

NCT ID: NCT00875381

Last Updated: 2011-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-12-31

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).

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic Rochester

Principal Investigators

Lawrence E Gibson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

07-002038

Identifier Type: -

Identifier Source: org_study_id