Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-30 @ 9:47 PM
Study NCT ID:
NCT03240835
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D044342', 'term': 'Malnutrition'}], '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': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-29', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of PA/RBP/TRSF', 'timeFrame': 'baseline and during treatment', 'description': 'to evaluate the changes of PA/RBP/TRSF during the treatment'}], 'secondaryOutcomes': [{'measure': 'Change of Body weight', 'timeFrame': 'baseline and during treatment', 'description': 'to compare the change of weight loss during treatment'}, {'measure': 'Number of Participants With Abnormal Laboratory Values', 'timeFrame': 'baseline and during treatment', 'description': 'To observe the complete blood cell count and blood biochemical examination during treatment'}, {'measure': 'Acute Toxicity', 'timeFrame': 'baseline and during treatment', 'description': 'To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pre-Albumin', 'Retinol Conjugated Protein', 'Transferrin', 'Locoregionally Advanced Nasopharyngeal Carcinoma', 'nutrition'], 'conditions': ['Nasopharyngeal Carcinoma', 'Malnutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic diagnosis of World Health Organization(WHO) II/III', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)\n* All genders，range from 18～60 years old\n* Karnofsky performance status(KPS) ≥ 80\n* Clinical stage III\\~IVb(UICC 8th)\n* Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease\n* Without significant cardiac，respiratory，kidney or liver disease\n* Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)\n* white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L\n* alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \\< 1.5×upper limit of normal(ULN), bilirubin \\< 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min\n* Inform consent form\n\nExclusion Criteria:\n\n* Distance metastases\n* Second malignancy within 5 years\n* Drug or alcohol addition\n* Do not have full capacity for civil acts\n* Active systemic infections\n* Chronic consumptions\n* Mental disorder\n* Pregnancy or lactation\n* Concurrent immunotherapy or hormone therapy for other diseases\n* Severe complication, eg, uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT03240835', 'briefTitle': 'The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy', 'orgStudyIdInfo': {'id': 'NPC-PA/RBP/TRSF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CCRT±NACT', 'description': 'Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only', 'interventionNames': ['Drug: cisplatin and docetaxel', 'Radiation: IMRT']}], 'interventions': [{'name': 'cisplatin and docetaxel', 'type': 'DRUG', 'description': 'NACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles.\n\nCCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.', 'armGroupLabels': ['CCRT±NACT']}, {'name': 'IMRT', 'type': 'RADIATION', 'description': 'intensity modulation radiation therapy', 'armGroupLabels': ['CCRT±NACT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Cancer Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhao Chong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wu Jieping Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zhao Chong', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}