Clinical trial NCT02576769: The Role of Melanocyte in Basal Cell Carcinoma
Official title: Melanocyte Features and Its Influence in Pigmentation in Basal Cell Carcinoma in the Mexican Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Basal Cell Carcinoma
Keywords: Basal cell carcinoma
Pigmentation
Melanocyte
Melanin
Skin cancer
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
Collaborators: name: Hospital Central "Dr. Ignacio Morones Prieto"
First posted: 2015-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologic diagnosis of basal cell carcinoma

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Mexican subjects
* Age between 40 and 90 years
* Both genders
* Sign informed consent

Exclusion Criteria:

* Sign informed consent withdrawal

Primary outcomes:
measure: Melanocyte number
timeFrame: Up to 1 year
measure: Melanocyte phenotype
timeFrame: Up to 1 year
measure: Melanogenesis characteristics
timeFrame: Up to 1 year
Secondary outcomes:
measure: Melanin presence
timeFrame: Up to 1 year
measure: Vessels number (angiogenesis)
timeFrame: Up to 1 year
measure: Mast cells number
timeFrame: Up to 1 year
measure: Solar elastosis quantity
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
Study officials:
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Juan P Castanedo-Cazares, MD, MSc
role: STUDY_DIRECTOR
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Bertha Torres-Alvarez, MD
role: STUDY_CHAIR
References:
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. doi: 10.1034/j.1600-0560.2001.280104.x.
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. doi: 10.1111/j.1600-0749.2004.00156.x.
citation: 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.