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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00875381 |
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.
Condition |
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Carcinoma, Basal Cell Carcinoma, Squamous Cell |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Immunohistochemical Analysis of Melanocytes in Sun-Exposed Skin |
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.
Enrollment: | 100 |
Study Start Date: | September 2007 |
Study Completion Date: | December 2007 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
A total of 50 patients from Mayo Clinic Jacksonville and 50 Mayo Clinic Rochester will be enrolled in this study.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Mayo Clinic Rochester ( Lawrence E. Gibson, M.D. ) |
Study ID Numbers: | 07-002038 |
Study First Received: | April 2, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00875381 History of Changes |
Health Authority: | United States: Institutional Review Board |
Melanocytes |
Neoplasms, Basal Cell Carcinoma, Basal Cell Neoplasms, Squamous Cell |
Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Carcinoma, Basal Cell |
Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial Carcinoma |