Basal Cell CarcinomaNCT02576769
The Role of Melanocyte in Basal Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2015to Dec 2016
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with histologic diagnosis of basal cell carcinoma
Who may be able to join
- Mexican subjects
- Age between 40 and 90 years
- Both genders
- Sign informed consent
Who cannot join
- Sign informed consent withdrawal
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, San Luis Potosí, 78210
Juan P Castanedo-Cazares, MD, MSc, 4448342795, castanju@yahoo.com
Bertha Torres-Alvarez, MD, 4448342795, torresmab@yahoo.com.mx
About this study
Official title: Melanocyte Features and Its Influence in Pigmentation in Basal Cell Carcinoma in the Mexican Population
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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- No intervention
- Keywords
- Basal cell carcinoma, Pigmentation, Melanocyte, Melanin, Skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Basal cell carcinoma | Basal cell carcinoma Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanocyte number
To quantify the number of melanocytes in basal cell carcinoma
Measured: Up to 1 year
Melanocyte phenotype
To quantify melanocyte maturation stages in basal cell carcinoma through markers
Measured: Up to 1 year
Melanogenesis characteristics
To quantify the expression of melanogenic markers in basal cell carcinoma
Measured: Up to 1 year
Secondary outcomes (4)
Melanin presence
To quantify melanin deposition in basal cell carcinoma using special histologic stains (Fontana-Masson)
Measured: Up to 1 year
Vessels number (angiogenesis)
To quantify number of vessels in basal cell carcinoma using special histologic stains (Elastic fibers)
Measured: Up to 1 year
Mast cells number
To quantify melanocytes in basal cell carcinoma using special histologic stains (Giemsa)
Measured: Up to 1 year
Solar elastosis quantity
To quantify solar elastosis in basal cell carcinoma using special histologic stains (Elastic fibers)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Principal investigator, Juan Pablo Castanedo-Cazares, Universidad Autonoma de San Luis Potosí
- Investigators
- 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"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576769
- Sponsor's protocol ID
- BCC1
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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 11168750Sakuraba 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 15250939Frey 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanocyte Features and Its Influence in Pigmentation in Basal Cell Carcinoma in the Mexican Population
- ClinicalTrials.gov ID
- NCT02576769
- Acronym / sponsor ID
- BCC1
- Conditions
- Basal Cell Carcinoma
- Keywords
- Basal cell carcinoma, Pigmentation, Melanocyte, Melanin, Skin cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Collaborators
- Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Oct 2015 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basal cell carcinoma | – | Other: No interventionBasal cell carcinoma |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologic diagnosis of basal cell carcinoma
Key inclusion criteria (4 listed)
- Mexican subjects
- Age between 40 and 90 years
- Both genders
- Sign informed consent
Key exclusion criteria (1 listed)
- Sign informed consent withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Basal cell carcinoma |
Primary outcome
Melanocyte number
Time frame: Up to 1 year
To quantify the number of melanocytes in basal cell carcinoma
Melanocyte phenotype
Time frame: Up to 1 year
To quantify melanocyte maturation stages in basal cell carcinoma through markers
Melanogenesis characteristics
Time frame: Up to 1 year
To quantify the expression of melanogenic markers in basal cell carcinoma
4 secondary outcomes
Melanin presence
Time frame: Up to 1 year
Vessels number (angiogenesis)
Time frame: Up to 1 year
Mast cells number
Time frame: Up to 1 year
Solar elastosis quantity
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Background: PubMed 11168750Lao 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.
- Background: PubMed 15250939Sakuraba 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.
- Background: PubMed 21152129Frey 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.
Related trials for Basal Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
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.
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"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan P Castanedo-Cazares, MD, MSc (4448342795, castanju@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melanocyte number (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02576769, which also lists 3 linked publications.
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 Oct 2015.