Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-04-05 @ 12:18 AM
Study NCT ID:
NCT02576769
Status:
UNKNOWN
Last Update Posted:
2015-10-15
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Melanocyte in Basal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2015-10-13', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Melanocyte number', 'timeFrame': 'Up to 1 year', 'description': 'To quantify the number of melanocytes in basal cell carcinoma'}, {'measure': 'Melanocyte phenotype', 'timeFrame': 'Up to 1 year', 'description': 'To quantify melanocyte maturation stages in basal cell carcinoma through markers'}, {'measure': 'Melanogenesis characteristics', 'timeFrame': 'Up to 1 year', 'description': 'To quantify the expression of melanogenic markers in basal cell carcinoma'}], 'secondaryOutcomes': [{'measure': 'Melanin presence', 'timeFrame': 'Up to 1 year', 'description': 'To quantify melanin deposition in basal cell carcinoma using special histologic stains (Fontana-Masson)'}, {'measure': 'Vessels number (angiogenesis)', 'timeFrame': 'Up to 1 year', 'description': 'To quantify number of vessels in basal cell carcinoma using special histologic stains (Elastic fibers)'}, {'measure': 'Mast cells number', 'timeFrame': 'Up to 1 year', 'description': 'To quantify melanocytes in basal cell carcinoma using special histologic stains (Giemsa)'}, {'measure': 'Solar elastosis quantity', 'timeFrame': 'Up to 1 year', 'description': 'To quantify solar elastosis in basal cell carcinoma using special histologic stains (Elastic fibers)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Basal cell carcinoma', 'Pigmentation', 'Melanocyte', 'Melanin', 'Skin cancer'], 'conditions': ['Basal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '11168750', 'type': 'BACKGROUND', '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.'}, {'pmid': '15250939', 'type': 'BACKGROUND', '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.'}, {'pmid': '21152129', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nIf 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologic diagnosis of basal cell carcinoma', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mexican subjects\n* Age between 40 and 90 years\n* Both genders\n* Sign informed consent\n\nExclusion Criteria:\n\n* Sign informed consent withdrawal'}, 'identificationModule': {'nctId': 'NCT02576769', 'briefTitle': 'The Role of Melanocyte in Basal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de San Luis Potosí'}, 'officialTitle': 'Melanocyte Features and Its Influence in Pigmentation in Basal Cell Carcinoma in the Mexican Population', 'orgStudyIdInfo': {'id': 'BCC1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basal cell carcinoma', 'description': 'Basal cell carcinoma', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Basal cell carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78210', 'city': 'San Luis Potosí City', 'state': 'San Luis Potosí', 'country': 'Mexico', 'contacts': [{'name': 'Juan P Castanedo-Cazares, MD, MSc', 'role': 'CONTACT', 'email': 'castanju@yahoo.com', 'phone': '4448342795'}, {'name': 'Bertha Torres-Alvarez, MD', 'role': 'CONTACT', 'email': 'torresmab@yahoo.com.mx', 'phone': '4448342795'}, {'name': 'Juan P Castanedo-Cazares, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bertha Torres-Alvarez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karla Martinez-Rosales, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Central Dr. Ignacio Morones Prieto', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}], 'centralContacts': [{'name': 'Juan P Castanedo-Cazares, MD, MSc', 'role': 'CONTACT', 'email': 'castanju@yahoo.com', 'phone': '4448342795'}, {'name': 'Bertha Bertha Torres-Alvarez, MD', 'role': 'CONTACT', 'email': 'torresmab@yahoo.com.mx', 'phone': '4448342795'}], 'overallOfficials': [{'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', 'affiliation': 'Hospital Central "Dr. Ignacio Morones Prieto"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de San Luis Potosí', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Central "Dr. Ignacio Morones Prieto"', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Juan Pablo Castanedo-Cazares', 'investigatorAffiliation': 'Universidad Autonoma de San Luis Potosí'}}}}