- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576769
The Role of Melanocyte in Basal Cell Carcinoma
Melanocyte Features and Its Influence in Pigmentation in Basal Cell Carcinoma in the Mexican Population
Study Overview
Detailed Description
Melanocytes are highly specialized dendritic cells that performs multiple functions through autocrine, paracrine and endocrine mechanisms. These cells are part of a complex system of intercellular communication along with keratinocytes, Langerhans cells and fibroblasts. This intricate network of cellular communication is possible thanks to interaction with cytokines, growth factors and neurotransmitters. Although melanocytes perform brilliantly immunoregulatory and neuroendocrine functions, their fundamental role is to offer protection against the harmful effects of UV radiation through production and transference of melanin to keratinocytes, a process better known as melanogenesis. The latter requires 3 basic proteins to ensure photoprotection: MC1R (activation), MITF (traduction) and TYR (melanin synthesis).
If one of the main features of melanocytes is to avoid UV radiation injurious effect, thus it raises many questions regarding the possible relation between these cells and skin cancer. Currently a great number of melanocytic alterations have been described in melanoma; however in non-melanoma skin cancer the role of melanocytes is less clear. Basal cell carcinoma (BCC) is the most frequent neoplasia worldwide. There are more than 30 histopathologic subtypes, however the nodular subtype is the most common. Pigmented varieties are common in darker skin types, therefore in our country. Previous studies have shown an increase number and size of melanocytes. Melanogenesis were increased at the expense of hyperfunctioning melanocytes as well. In our experience we have noticed the clinical course regarding pigmented nodular basal cell carcinoma is more benign when compared to those without pigment. Most studies regarding the role of melanocytes and pigmentation in basal cell carcinoma have been conducted in caucasian populations, and therefore not representative of what may occur in mestizo population. The aim of the study was to describe the characteristics of melanocytes in pigmented and non-pigmented variants of basal cell carcinoma. Quantify the expression of melanocytic maturation: transcription factors (SOX9 and SOX10), focal adhesion kinase (FAK125) and receptor tyrosine kinase (c-KIT) and melanogenesis such as melanocortin 1 receptor (MC1R), microphthalmia-associated transcription factor (MITF) and tyrosinase (TYR) markers. Investigate the tumoral microenvironment through the quantification of melanin, mast cells, angiogenesis and solar elastosis.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Bertha Bertha Torres-Alvarez, MD
- Phone Number: 4448342795
- Email: torresmab@yahoo.com.mx
Study Locations
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San Luis Potosi, Mexico, 78210
- Hospital Central Dr. Ignacio Morones Prieto
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Principal Investigator:
- Juan P Castanedo-Cazares, MD, MSc
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Sub-Investigator:
- Karla Martinez-Rosales, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Mexican subjects
- Age between 40 and 90 years
- Both genders
- Sign informed consent
Exclusion Criteria:
- Sign informed consent withdrawal
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Basal cell carcinoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Melanocyte number
Time Frame: Up to 1 year
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To quantify the number of melanocytes in basal cell carcinoma
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Up to 1 year
|
Melanocyte phenotype
Time Frame: Up to 1 year
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To quantify melanocyte maturation stages in basal cell carcinoma through markers
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Up to 1 year
|
Melanogenesis characteristics
Time Frame: Up to 1 year
|
To quantify the expression of melanogenic markers in basal cell carcinoma
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Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Melanin presence
Time Frame: Up to 1 year
|
To quantify melanin deposition in basal cell carcinoma using special histologic stains (Fontana-Masson)
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Up to 1 year
|
Vessels number (angiogenesis)
Time Frame: Up to 1 year
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To quantify number of vessels in basal cell carcinoma using special histologic stains (Elastic fibers)
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Up to 1 year
|
Mast cells number
Time Frame: Up to 1 year
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To quantify melanocytes in basal cell carcinoma using special histologic stains (Giemsa)
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Up to 1 year
|
Solar elastosis quantity
Time Frame: Up to 1 year
|
To quantify solar elastosis in basal cell carcinoma using special histologic stains (Elastic fibers)
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Up to 1 year
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Bertha Torres-Alvarez, MD, Hospital Central "Dr. Ignacio Morones Prieto"
- Study Director: Juan P Castanedo-Cazares, MD, MSc, Hospital Central "Dr. Ignacio Morones Prieto"
Publications and helpful links
General Publications
- Lao LM, Kumakiri M, Kiyohara T, Kuwahara H, Ueda K. Sub-populations of melanocytes in pigmented basal cell carcinoma: a quantitative, ultrastructural investigation. J Cutan Pathol. 2001 Jan;28(1):34-43. doi: 10.1034/j.1600-0560.2001.280104.x.
- Sakuraba K, Hayashi N, Kawashima M, Imokawa G. Down-regulated PAR-2 is associated in part with interrupted melanosome transfer in pigmented basal cell epithelioma. Pigment Cell Res. 2004 Aug;17(4):371-8. doi: 10.1111/j.1600-0749.2004.00156.x.
- Frey LM, Houben R, Brocker EB. Pigmentation, Melanocyte Colonization, and p53 Status in Basal Cell Carcinoma. J Skin Cancer. 2011;2011:349726. doi: 10.1155/2011/349726. Epub 2010 Sep 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCC1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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