CClinicalTrials.gg
Status unknownNCT02576769Updated Oct 15, 2015

The Role of Melanocyte in Basal Cell Carcinoma

An observational study in Basal Cell Carcinoma, sponsored by Universidad Autonoma de San Luis Potosí. Status unknown at 1 site in Mexico. Open to participants aged 40 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-15.

Sponsored by Universidad Autonoma de San Luis Potosí · Observational

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
40 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Basal Cell Carcinoma

Keywords

  • Basal cell carcinoma
  • Pigmentation
  • Melanocyte
  • Melanin
  • Skin cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 30 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Universidad Autonoma de San Luis Potosí is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with histologic diagnosis of basal cell carcinoma

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Sign informed consent withdrawal
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Basal cell carcinoma

    Basal cell carcinoma

    Other: No intervention

Interventions

  • OtherNo intervention
06

What researchers measure

Primary outcomes

  1. Melanocyte number

    To quantify the number of melanocytes in basal cell carcinoma

    Time frame: Up to 1 year

  2. Melanocyte phenotype

    To quantify melanocyte maturation stages in basal cell carcinoma through markers

    Time frame: Up to 1 year

  3. Melanogenesis characteristics

    To quantify the expression of melanogenic markers in basal cell carcinoma

    Time frame: Up to 1 year

Secondary outcomes

  1. Melanin presence

    To quantify melanin deposition in basal cell carcinoma using special histologic stains (Fontana-Masson)

    Time frame: Up to 1 year

  2. Vessels number (angiogenesis)

    To quantify number of vessels in basal cell carcinoma using special histologic stains (Elastic fibers)

    Time frame: Up to 1 year

  3. Mast cells number

    To quantify melanocytes in basal cell carcinoma using special histologic stains (Giemsa)

    Time frame: Up to 1 year

  4. Solar elastosis quantity

    To quantify solar elastosis in basal cell carcinoma using special histologic stains (Elastic fibers)

    Time frame: Up to 1 year

07

Study locations

1 site
  • Hospital Central Dr. Ignacio Morones Prieto
    San Luis Potosi, 78210, Mexico
    • Juan P Castanedo-Cazares, MD, MSc · Contact · castanju@yahoo.com · 4448342795
    • Bertha Torres-Alvarez, MD · Contact · torresmab@yahoo.com.mx · 4448342795
    • Juan P Castanedo-Cazares, MD, MSc · Principal investigator
    • Bertha Torres-Alvarez, MD · Sub investigator
    • Karla Martinez-Rosales, MD · Sub investigator
08

References and documents

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. PubMed 11168750 ↗
  • 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. PubMed 15250939 ↗
  • 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. PubMed 21152129 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02576769
Lead sponsor
Universidad Autonoma de San Luis Potosí
Collaborators
Hospital Central "Dr. Ignacio Morones Prieto"
Responsible party
Juan Pablo Castanedo-Cazares (Study Director, Universidad Autonoma de San Luis Potosí) — Principal investigator
First posted
Oct 15, 2015
Start date
Nov 2015
Primary completion
Nov 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Oct 15, 2015

Study contacts

Juan P Castanedo-Cazares, MD, MSc
Contact
castanju@yahoo.com
4448342795
Bertha Bertha Torres-Alvarez, MD
Contact
torresmab@yahoo.com.mx
4448342795
Juan P Castanedo-Cazares, MD, MSc
study director · Hospital Central "Dr. Ignacio Morones Prieto"
Bertha Torres-Alvarez, MD
study chair · Hospital Central "Dr. Ignacio Morones Prieto"

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion