Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 2, 2009 | ||||
| Last Updated Date | March 14, 2011 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00875381 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin | ||||
| Official Title ICMJE | Immunohistochemical Analysis of Melanocytes in Sun-Exposed Skin | ||||
| 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). |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: 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. |
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | A total of 50 patients from Mayo Clinic Jacksonville and 50 Mayo Clinic Rochester will be enrolled in this study. |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00875381 | ||||
| Other Study ID Numbers ICMJE | 07-002038 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lawrence E. Gibson, M.D., Mayo Clinic Rochester | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Mayo Clinic | ||||
| Verification Date | March 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||