Carcinoma, Basal CellNCT00875381
Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin
An observational study of Carcinoma, Basal Cell and Carcinoma, Squamous Cell, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 50 patients from Mayo Clinic Jacksonville and 50 Mayo Clinic Rochester will be enrolled in this study.
Who may be able to join
- Participants undergoing Mohs and reconstructive surgery for basal cell and squamous cell carcinoma of the face and neck
Who cannot join
- Participants with a history of radiation to the head and neck were excluded.
About this study
Official title: Immunohistochemical Analysis of Melanocytes 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.
Read the 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
- Keywords
- Melanocytes
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Lawrence E Gibson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875381
- Sponsor's protocol ID
- 07-002038
- Status last verified
- Mar 2011
- First submitted
- 2 Apr 2009
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Analysis of Melanocytes in Sun-Exposed Skin
- ClinicalTrials.gov ID
- NCT00875381
- Acronym / sponsor ID
- 07-002038
- Conditions
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell
- Keywords
- Melanocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 patients from Mayo Clinic Jacksonville and 50 Mayo Clinic Rochester will be enrolled in this study.
Key inclusion criteria (1 listed)
- Participants undergoing Mohs and reconstructive surgery for basal cell and squamous cell carcinoma of the face and neck
Key exclusion criteria (1 listed)
- Participants with a history of radiation to the head and neck were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence E Gibson, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Basal Cell and Carcinoma, Squamous Cell, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2011.