Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-29 @ 12:50 AM
Study NCT ID:
NCT05682703
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2023-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Nasopharyngeal Carcinoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073890', 'term': 'Liquid Biopsy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achieve the expected number of enrolled cases', 'timeFrame': '3 years', 'description': 'Achieve the expected number of enrolled cases'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma', 'EBV Infection']}, 'descriptionModule': {'briefSummary': 'The transformation process of nasopharyngeal carcinoma is complex, so it is particularly important to explore the relationship between various disease states on its clinical pathway. Therefore, we carried out this study to explore the changes of plasma and urine metabolites at different stages during the occurrence and development of nasopharyngeal carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who met the diagnosis and criteria and were admitted to Nanfang Hospital of Southern Medical University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EBV virus infector: QPCR/EBV antibody, diagnosed as EBV infection patient with previous infection;\n* Nasopharyngeal carcinoma patients:Patients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard);\n* Healthy people: Healthy people who have no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism and have been hospitalized in the Physical Examination Center of Southern Hospital.\n\nExclusion Criteria:\n\n1. People who have a history of non research related liver diseases or other diseases known to affect blood metabolism (except for controlled type II diabetes);\n2. Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ;\n3. Diseases requiring long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency diseases or active central nervous system metastatic cancer, active infection or uncontrolled heart disease;\n4. Suffer from other uncontrolled serious diseases at the same time, such as unstable heart disease requiring treatment, diabetes with unsatisfactory control (fasting blood glucose\\>1.5 × Upper limit of normal value), mental illness and severe allergic history.\n5. BMI is less than 18 or more than 25. -'}, 'identificationModule': {'nctId': 'NCT05682703', 'briefTitle': 'A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Nasopharyngeal Carcinoma.', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Nasopharyngeal Carcinoma in Southern China.', 'orgStudyIdInfo': {'id': 'NFEC-2022-470'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EBV virus infector', 'description': 'QPCR/EBV antibody, diagnosed as EBV infection patient', 'interventionNames': ['Diagnostic Test: Proteomics technology and liquid biopsy']}, {'label': 'nasopharyngeal carcinoma patients', 'description': 'Patients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard)', 'interventionNames': ['Diagnostic Test: Proteomics technology and liquid biopsy']}, {'label': 'Healthy people', 'description': 'healthy people with no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism', 'interventionNames': ['Diagnostic Test: Proteomics technology and liquid biopsy']}], 'interventions': [{'name': 'Proteomics technology and liquid biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'using proteomics technology and liquid biopsy to investigate the changes of plasma and urine metabolites by collecting residual blood and urine from routine diagnosis and treatment or physical examination', 'armGroupLabels': ['EBV virus infector', 'Healthy people', 'nasopharyngeal carcinoma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Guan, M.D.', 'role': 'CONTACT', 'email': 'guanjian5461@163.com', 'phone': '86+13632102247'}, {'name': 'Jian Guan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'jian guan, MD', 'role': 'CONTACT', 'email': 'guanjian5461@163.com', 'phone': '136 3210 2247'}], 'overallOfficials': [{'name': 'jian guan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}