Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-22 @ 2:26 AM
Study NCT ID:
NCT03704233
Status:
UNKNOWN
Last Update Posted:
2019-03-07
First Post:
2018-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-06', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnotic yield', 'timeFrame': 'two weeks', 'description': 'Percentage of definitive pathological diagnosis by transbronchial cryobiopsy, the alteration of original diagnosis after transbronchial cryobiopsy'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '12 weeks', 'description': 'Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention) and exacerbations of DPLD related to the transbronchial cryobiopsy (in 12 weeks).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transbrochial cryobiopsy', 'Diffuse parenchymal lung diseases', 'Diagnosis'], 'conditions': ['Diffuse Parenchymal Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '34988154', 'type': 'DERIVED', 'citation': 'Chen X, Li J, Luo F, Tao F, Zhang X, Wu Y, Xu P, Ke M, Long F, Liu L, Lv L, Liao H, Gu Y, Liu Z, Tan X, Guo S, Hu Y, Yang H, Zhou Y, Zhou H, Ye Y, Chen D, Li S. The application of transbronchial cryobiopsy in interstitial lung disease: a prospective, multicenter, real-world study. Ann Transl Med. 2021 Nov;9(22):1645. doi: 10.21037/atm-21-3461.'}]}, 'descriptionModule': {'briefSummary': 'The Diagnostic yield and Safety of transbronchial cryobiopsy in the diagnosis of diffuse parenchymal lung diseases are investigated in this multicenter, prospective and real world study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.\n2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.\n3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.\n\nExclusion Criteria:\n\n1. The radiological data indicates non-DPLD\n2. The clinical examinations mentioned above are not completed.\n3. The patient cannot endure or does not agree the procedure.'}, 'identificationModule': {'nctId': 'NCT03704233', 'briefTitle': 'The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou Institute of Respiratory Disease'}, 'officialTitle': 'The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Diffuse Parenchymal Lung Diseases: a Prospective, Multicenter, Real World Study', 'orgStudyIdInfo': {'id': '2018-03-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cryobiopsy', 'description': 'Transbronchial cryobiopsy is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.', 'interventionNames': ['Procedure: Transbronchial cryobiopsy']}], 'interventions': [{'name': 'Transbronchial cryobiopsy', 'type': 'PROCEDURE', 'description': 'Transbronchial cryobiopsy procedure', 'armGroupLabels': ['Cryobiopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230003', 'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liping Lv, BD', 'role': 'CONTACT', 'email': 'Lvliping1759@sina.com', 'phone': '13956954712'}, {'name': 'Fei Tang, MD', 'role': 'CONTACT', 'email': 'tangfei1205@163.com', 'phone': '13505696936'}], 'facility': 'AnHui Chest Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Wang, PhD', 'role': 'CONTACT', 'email': 'wang_xpx@163.com', 'phone': '18600569233'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuliang Guo, PhD', 'role': 'CONTACT', 'email': 'GUOSL999@sina.com', 'phone': '023-89012097'}, {'name': 'Yishi Li, MD', 'role': 'CONTACT', 'email': 'KEVIN2003LEE@163.com', 'phone': '023-89012692'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '361021', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Yao Ke, BD', 'role': 'CONTACT', 'email': '13860166866@126.com', 'phone': '13860166866'}, {'name': 'Rui Huang, BD', 'role': 'CONTACT', 'email': 'huangrui_0805@163.com', 'phone': '15392037355'}], 'facility': 'Xiamen Second Hospital', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Li, PhD', 'role': 'CONTACT', 'email': '472522080@qq.com', 'phone': '13825009393'}, {'name': 'Wenfang Chen, BD', 'role': 'CONTACT', 'email': '823238179@qq.com', 'phone': '17701966969'}], 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huai Liao, MD', 'role': 'CONTACT', 'email': 'liaohuai1208@hotmail.com', 'phone': '020-87755766-8171'}, {'name': 'Xinyan Huang, PhD', 'role': 'CONTACT', 'phone': '020-87755766-8171'}], 'facility': 'the First Affiliated Hospital Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiyue Li, MD', 'role': 'CONTACT', 'email': 'lishiyue@188.com', 'phone': '8620-83062896'}, {'name': 'Xiaobo Chen, MD', 'role': 'CONTACT', 'email': 'xiaobo-win@163.com', 'phone': '8620-83062885'}, {'name': 'Shiyue Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaobo Chen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lai Yu Liu, PhD', 'role': 'CONTACT', 'email': 'liulaiyu@126.com', 'phone': '13632102245'}, {'name': 'Wen Qi Huang, MD', 'role': 'CONTACT', 'email': '494435398@163.com', 'phone': '13712920984'}], 'facility': 'Southern Medical University Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Xu, PhD', 'role': 'CONTACT', 'email': '799721206@qq.com', 'phone': '0755-83923333'}, {'name': 'WD Song, PhD', 'role': 'CONTACT', 'email': 'SongWD123@hotmail.com', 'phone': '0755-83923333'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '518106', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fa Long, MD', 'role': 'CONTACT', 'email': 'longfa_923@163.com', 'phone': '13651472098'}, {'name': 'Peng Fu, BD', 'role': 'CONTACT', 'email': '843999103@qq.com', 'phone': '15989380761'}], 'facility': "Shenzhen Guangming New District People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '528415', 'city': 'Zhongshan', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Mei Zhou, BD', 'role': 'CONTACT', 'email': 'zhouhongmei2011e@163.com', 'phone': '13822715685'}], 'facility': 'Affiliated Zhongshan Hospital of Guangdong Medical University', 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoju Zhang, PhD', 'role': 'CONTACT', 'email': '15837101166@163.com', 'phone': '0371-65580653'}, {'name': 'Quncheng Zhang, MD', 'role': 'CONTACT', 'email': 'zcc_0813@126.com', 'phone': '0371-65580330'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430014', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Hu, MD', 'role': 'CONTACT', 'email': 'huyi_pub@163.com', 'phone': '13995618974'}, {'name': 'Wen Yin, MD', 'role': 'CONTACT', 'email': 'evan_wen@126.com', 'phone': '15827232797'}], 'facility': 'The Central Hospital Of WuHan', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Ping Zhao, PhD', 'role': 'CONTACT', 'email': 'zhaojp88@126.com', 'phone': '02783663615'}, {'name': 'Peng Zuo, MD', 'role': 'CONTACT', 'email': 'zuopeng1123@163.com', 'phone': '02783663617'}], 'facility': 'Department of Respiratory and Critical Care Medicine，Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410005', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiguang Liu, MD', 'role': 'CONTACT', 'email': 'liuzhiguang0404@126.com', 'phone': '073183928074'}, {'name': 'Wei Liu, PhD', 'role': 'CONTACT', 'phone': '073183920874'}], 'facility': "People's Hospital of Hunan Province", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Ping Yang, PhD', 'role': 'CONTACT', 'email': 'lyhuaping@aliyun.com', 'phone': '13973129956'}], 'facility': 'XiangYa Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '116033', 'city': 'Dalian', 'state': 'Liaoning', 'status': 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'18729378033@163.com', 'phone': '02962500170'}, {'name': 'Chao Ruan, BD', 'role': 'CONTACT', 'email': '1225980995@qq.com', 'phone': '02962500170'}], 'facility': "Xi'an chest hospital", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Ming Luo, PhD', 'role': 'CONTACT', 'email': 'luofengming@hotmail.com', 'phone': '18980601355'}, {'name': 'Dan Liu, PhD', 'role': 'CONTACT', 'email': '1103432159@qq.com', 'phone': '028-85422580'}], 'facility': 'West China School of Medicine/West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '621000', 'city': 'Mianyang', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'You Lv Wu, BD', 'role': 'CONTACT', 'email': '18981117387@163.com', 'phone': '13778138872'}], 'facility': 'MianYang Central Hospital', 'geoPoint': {'lat': 31.46784, 'lon': 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'email': 'xiaobo-win@163.com', 'phone': '8620-83062885'}], 'overallOfficials': [{'name': 'Shiyue Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Institute of Respiratory Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Respiratory Medicine', 'investigatorFullName': 'ShiYue Li', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}