Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-29 @ 5:00 PM
Study NCT ID:
NCT04759261
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2021-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D055623', 'term': 'Keratosis, Actinic'}], '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': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008745', 'term': 'Methylation'}], 'ancestors': [{'id': 'D000478', 'term': 'Alkylation'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D055601', 'term': 'Organic Chemistry Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Differantiation of tumor tissues than normal tissues in same patients.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of SMAD4 methylations and expression', 'timeFrame': '2 years', 'description': 'Detection of SMAD4 methylations on tumor tissues'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Basal Cell Carcinoma', 'Squamose Cell Carcinoma', 'Actinic Keratoses', 'SMAD4 methylation', 'SMAD4 expression'], 'conditions': ['Basal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37428273', 'type': 'DERIVED', 'citation': 'Gursel Urun Y, Budak M, Usturali Keskin E. Methylation status, mRNA and protein expression of the SMAD4 gene in patients with non-melanocytic skin cancers. Mol Biol Rep. 2023 Sep;50(9):7295-7304. doi: 10.1007/s11033-023-08656-2. Epub 2023 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'Non-melanocytic skin cancers are the most common type of cancer worldwide. In the development of this cancer type, environmental factors such as UV and smoking are emphasized.\n\nEpigenetics are genetic conditions that develop due to environmental factors and can be inherited. Epigenetic modifications such as DNA methylation play an integral role in carcinogenesis, cancer progression and metastasis.\n\nThe TGF-/ SMAD4 pathway plays a tumor suppressive role in cancer pathogenesis. Epigenetic changes in this pathway also lead to a decrease in expression level, leading to different types of cancer. However, there is no study showing the epigenetic relationship between non-melanocytic skin cancer and SMAD4 methylation.\n\nIn this study we planned, it was aimed to show the change in SMAD4 methylation and SMAD4 RNA expression level in cancerous tissue. In addition, it is planned to measure the SMAD4 protein positivity rate in non-melanocytic cancers as an immunohistochemical marker.\n\nIn this context, 60 patients who applied to Trakya University Dermatology and Venereal Diseases Outpatient Clinic and diagnosed with non-melanocytic skin cancer clinically and dermoscopically will be included in the study. Tissue materials obtained from both cancerous and intact skin of the patients will be examined in Trakya University Medical Biophysics and Medicine Pathology laboratories through various steps.\n\nOur project is the first study to be conducted on this subject in terms of handling all non-melanocytic skin cancers, using human tissue and having a large sample.\n\nIn addition, with the data to be obtained; We think that better clarification of the role of SMAD4 in non-melanocytic cancers and the use of SMAD4 as both a prognostic factor and an immunohistochemical marker in future studies will prevent this study.\n\nAgain, we anticipate that different treatment modalities will be developed and different functional studies can be designed through this pathway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. People diagnosed clinically and dermoscopically with non-melanocytic skin cancer\n2. No other cancer history\n3. over 18 years old\n4. Newly diagnosed\n5. No systemic or topical therapy\n\nExclusion Criteria:\n\n1. Under 18 and pregnant\n2. People with non-melanocytic skin cancer who are in the process of follow-up and treatment\n3. has another cancer history'}, 'identificationModule': {'nctId': 'NCT04759261', 'briefTitle': 'SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'SMAD4 Methylation and Expression Levels in Non-melanocytic Skin Cancers; SMAD4 Protein Positivity', 'orgStudyIdInfo': {'id': '2020/55'}, 'secondaryIdInfos': [{'id': 'SMAD4', 'type': 'OTHER', 'domain': 'Trakya University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study group', 'interventionNames': ['Other: SMAD4 expression and methylation']}], 'interventions': [{'name': 'SMAD4 expression and methylation', 'type': 'OTHER', 'description': 'Effect of SMAD4 methylations on smad4 expression', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22000', 'city': 'Edirne', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yildiz Gursel, MD', 'role': 'CONTACT', 'email': 'ygurselu@gmail.com', 'phone': '+905055373063'}, {'name': 'Metin Budak, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fatma El Ustrali Keskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Trakya University', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'centralContacts': [{'name': 'Yildiz Gursel, MD', 'role': 'CONTACT', 'email': 'yildizgrsl@gmail.com', 'phone': '90 505 537 30 63'}], 'overallOfficials': [{'name': 'Metin Budak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University'}, {'name': 'Fatma El Usturali Keskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University'}, {'name': 'Yildiz Gursel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trakya University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asist. Prof. Dr.', 'investigatorFullName': 'Metin Budak', 'investigatorAffiliation': 'Trakya University'}}}}