Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin | NCT00875381

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

NCT00875381

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 15, 2011Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Carcinoma, Basal Cell
Carcinoma, Squamous Cell

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Apr 2, 2009

First Submission Date that Met QC Criteria

Apr 2, 2009

First Posted Date

Apr 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2011

Last Update Posted Date

Mar 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A total of 50 patients from Mayo Clinic Jacksonville and 50 Mayo Clinic Rochester will be enrolled in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence E Gibson, MD	Mayo Clinic	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002280	Carcinoma, Basal Cell
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

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.