Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-25 @ 12:56 AM
Study NCT ID:
NCT03686020
Status:
UNKNOWN
Last Update Posted:
2019-07-23
First Post:
2018-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2018-09-24', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer', 'timeFrame': 'one year', 'description': 'diagnostic accuracy in terms of sensitivity and specificity of serum and salivary CYFRA21-1 in differentiating between oral malignancy and oral potential malignant lesions in order to be able to early diagnose malignant changes in oral lesions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral potentially malignant lesions', 'Oral cancer', 'salivary CYFRA21-1', 'serum CYFRA21-1'], 'conditions': ['Oral Potentially Malignant Lesions', 'Oral Cancer']}, 'referencesModule': {'references': [{'pmid': '24304502', 'type': 'BACKGROUND', 'citation': 'Rajkumar K, Ramya R, Nandhini G, Rajashree P, Ramesh Kumar A, Nirmala Anandan S. Salivary and serum level of CYFRA 21-1 in oral precancer and oral squamous cell carcinoma. Oral Dis. 2015 Jan;21(1):90-6. doi: 10.1111/odi.12216. Epub 2013 Dec 30.'}, {'pmid': '20651382', 'type': 'BACKGROUND', 'citation': 'Alkotyfan K, Wiegand S, Muller HH, Windfuhr JP, Werner JA, Sesterhenn AM. Cyfra 21-1 as a tumor marker for follow-up of patients with squamous cell carcinoma of the oropharynx. Anticancer Res. 2010 Jun;30(6):2291-6.'}, {'pmid': '29323056', 'type': 'BACKGROUND', 'citation': 'Awasthi N. Role of salivary biomarkers in early detection of oral squamous cell carcinoma. Indian J Pathol Microbiol. 2017 Oct-Dec;60(4):464-468. doi: 10.4103/IJPM.IJPM_140_16.'}, {'pmid': '26577643', 'type': 'BACKGROUND', 'citation': 'Gualtero DF, Suarez Castillo A. Biomarkers in saliva for the detection of oral squamous cell carcinoma and their potential use for early diagnosis: a systematic review. Acta Odontol Scand. 2016;74(3):170-7. doi: 10.3109/00016357.2015.1110249. Epub 2015 Nov 18.'}, {'pmid': '26779624', 'type': 'BACKGROUND', 'citation': 'Malhotra R, Urs AB, Chakravarti A, Kumar S, Gupta VK, Mahajan B. Correlation of Cyfra 21-1 levels in saliva and serum with CK19 mRNA expression in oral squamous cell carcinoma. Tumour Biol. 2016 Jul;37(7):9263-71. doi: 10.1007/s13277-016-4809-4. Epub 2016 Jan 15.'}, {'pmid': '25024833', 'type': 'BACKGROUND', 'citation': 'Mortazavi H, Baharvand M, Mehdipour M. Oral potentially malignant disorders: an overview of more than 20 entities. J Dent Res Dent Clin Dent Prospects. 2014 Winter;8(1):6-14. doi: 10.5681/joddd.2014.002. Epub 2014 Mar 5.'}, {'pmid': '24065233', 'type': 'BACKGROUND', 'citation': 'Wang YX, Hu D, Yan X. Diagnostic accuracy of Cyfra 21-1 for head and neck squamous cell carcinoma: a meta-analysis. Eur Rev Med Pharmacol Sci. 2013 Sep;17(17):2383-9.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Egyptian population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nparticipants will be divided into 3 groups:\n\n* Group I: patients suffering from oral potentially malignant lesions (PML) as defined by World Health Organization.\n* Group II: patients suffering from diagnosed oral malignant lesions\n* Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.\n\nExclusion Criteria:\n\n* Subjects taking any drugs inducing any changes that could affect the salivary flow.\n* Pregnant females.\n* Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.\n* Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.'}, 'identificationModule': {'nctId': 'NCT03686020', 'acronym': 'CYFRA21-1', 'briefTitle': 'Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)', 'orgStudyIdInfo': {'id': '1152014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'participants suffering from oral potentially malignant lesions', 'interventionNames': ['Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)']}, {'label': 'Group II', 'description': 'participants suffering from diagnosed oral malignant lesions', 'interventionNames': ['Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)']}, {'label': 'Group III', 'description': 'healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.', 'interventionNames': ['Diagnostic Test: Enzyme Linked Immunosorbent assay (ELISA)']}], 'interventions': [{'name': 'Enzyme Linked Immunosorbent assay (ELISA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)', 'armGroupLabels': ['Group I', 'Group II', 'Group III']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Salsabeel Ali Mahmoud, MD', 'role': 'CONTACT', 'email': 'salsabeel_ali@hotmail.com', 'phone': '01222343488'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Salsabeel A Mahmoud', 'role': 'CONTACT', 'email': 'salsabeel_ali@hotmail.com', 'phone': '00201222343488'}, {'name': 'Basma A Zakaria', 'role': 'CONTACT', 'email': 'basma.abdelalim@dentistry.cu.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD postgraduate student', 'investigatorFullName': 'Salsabeel Ali Mahmoud', 'investigatorAffiliation': 'Cairo University'}}}}