The Role of Melanocyte in Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

Official title:

Melanocyte Features and Its Influence in Pigmentation in Basal Cell Carcinoma in the Mexican Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02576769
• Other study ID #: BCC1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 13, 2015
• Last updated: October 13, 2015
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Universidad Autonoma de San Luis Potosí
• Contact: Juan P Castanedo-Cazares, MD, MSc
• Phone: 4448342795
• Email: castanju[@]yahoo.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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. The aim of the study was to describe the characteristics of melanocytes in pigmented and non-pigmented variants of basal cell carcinoma.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Mexican subjects

• Age between 40 and 90 years

• Both genders

• Sign informed consent

Exclusion Criteria:

• Sign informed consent withdrawal

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Mexico	Hospital Central Dr. Ignacio Morones Prieto	San Luis Potosi

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí	Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Frey LM, Houben R, Bröcker 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melanocyte number	To quantify the number of melanocytes in basal cell carcinoma	Up to 1 year	No
Primary	Melanocyte phenotype	To quantify melanocyte maturation stages in basal cell carcinoma through markers	Up to 1 year	No
Primary	Melanogenesis characteristics	To quantify the expression of melanogenic markers in basal cell carcinoma	Up to 1 year	No
Secondary	Melanin presence	To quantify melanin deposition in basal cell carcinoma using special histologic stains (Fontana-Masson)	Up to 1 year	No
Secondary	Vessels number (angiogenesis)	To quantify number of vessels in basal cell carcinoma using special histologic stains (Elastic fibers)	Up to 1 year	No
Secondary	Mast cells number	To quantify melanocytes in basal cell carcinoma using special histologic stains (Giemsa)	Up to 1 year	No
Secondary	Solar elastosis quantity	To quantify solar elastosis in basal cell carcinoma using special histologic stains (Elastic fibers)	Up to 1 year	No