Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-05 @ 7:35 PM
Study NCT ID:
NCT03666234
Status:
UNKNOWN
Last Update Posted:
2018-09-11
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Idiopathic Pulmonary Fibrosis Registry China Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2018-09-10', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic and clinical characteristic of newly diagnosed Chinese IPF patients', 'timeFrame': 'up to 5 years', 'description': 'Data analyses will be mainly descriptive.'}], 'secondaryOutcomes': [{'measure': 'Mortality in Chinese patients with IPF', 'timeFrame': 'up to 5 years', 'description': 'Mortality will be showed as percentage.'}, {'measure': 'Cause of death in Chinese patients with IPF', 'timeFrame': 'up to 5 years', 'description': 'Cause of death:\n\na. IPF-related: i. Respiratory failure: Pulmonary failure leads to impaired gas exchange, i.e. hypoxemia and/or hypercapnia ii. Acute exacerbation of IPF (as defined below) iii. Other aspects related to IPF (please specify); b. Concomitant conditions: i. Coronary heart disease ii. Cerebrovascular disease iii. Pneumonia/respiratory tract infection iv. Pulmonary embolism v. Pulmonary hypertension or pulmonary hypertension/right heart failure vi. Lung cancer; c. Other causes; d. Unknown.\n\nCause of death will be showed as categorical variable, and the counts and percentile ratios will be statistically counted.'}, {'measure': 'Progression-free survival in Chinese patients with IPF', 'timeFrame': 'up to 5 years', 'description': 'Patients without the following events:\n\n1. Death\n2. Lung transplantation\n3. Acute exacerbation\n4. Require long-term oxygen therapy\n5. Hospitalization for respiratory reasons\n\nThe unit of progression-free survival is day.'}, {'measure': 'Description of the acute exacerbations in Chinese patients with IPF', 'timeFrame': 'up to 5 years', 'description': 'Acute exacerbation of IPF (AE-IPF)\n\n1. Previous diagnosis or simultaneous diagnosis of IPF;\n2. Symptoms generally manifest as dyspnea with acute exacerbations or progression within 1 month;\n3. Chest CT shows new bilateral glass ground or solid shadows on the basis of usual interstitial pneumonia (UIP);\n4. Exacerbations cannot be completely explained by heart failure or increased volume load.\n\nThe incidence of the acute exacerbation will be showed as percentage.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'Epidemiology', 'Nature History'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '40087606', 'type': 'DERIVED', 'citation': 'Yang X, Wang H, Liu A, Ni Y, Wang J, Han Y, Xie B, Geng J, Ren Y, Zhang R, Liu M, Dai H. Evaluation of respiratory muscle dysfunction in patients with idiopathic pulmonary fibrosis: a prospective observational study with magnetic resonance imaging. BMC Pulm Med. 2025 Mar 14;25(1):118. doi: 10.1186/s12890-025-03572-6.'}, {'pmid': '33177132', 'type': 'DERIVED', 'citation': 'Xie B, Ren Y, Geng J, He X, Ban C, Wang S, Jiang D, Luo S, Chen Q, Liu M, Feng R, Zhao L, Dai H, Wang C. Idiopathic Pulmonary Fibrosis Registry China study (PORTRAY): protocol for a prospective, multicentre registry study. BMJ Open. 2020 Nov 11;10(11):e036809. doi: 10.1136/bmjopen-2020-036809.'}]}, 'descriptionModule': {'briefSummary': 'By mean of registry of newly diagnosed Chinese IPF patients from more than 15 sites, this study aims to build IPF prospective cohort, set up normative clinical database and a biological specimen bank, and examine the clinical characteristics of newly diagnosed Chinese IPF patients, as well as the nature history, prognosis, comorbidities and complications of IPF patients in China, the current treatment pattern, burden of illness, and quality of life of Chinese IPF patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese newly diagnosed IPF patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011\n* Aged 40 years and above at recruitment\n* Willing and able to sign an informed consent\n\nExclusion Criteria:\n\n* Inclusion in any interventional clinical trials\n* Lung transplantation expected within the next 6 months.'}, 'identificationModule': {'nctId': 'NCT03666234', 'acronym': 'PORTRAY', 'briefTitle': 'Idiopathic Pulmonary Fibrosis Registry China Study', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Idiopathic Pulmonary Fibrosis Registry China Study', 'orgStudyIdInfo': {'id': 'ChinaJapanFH002'}}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaping Dai', 'role': 'CONTACT', 'email': 'daihuaping@sina.com', 'phone': '0086-13901293597'}], 'facility': 'Huaping Dai', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dai Huaping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Center for Respiratory Diseases', 'investigatorFullName': 'Dai Huaping', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}