Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-02 @ 4:37 PM
Study NCT ID:
NCT04370158
Status:
UNKNOWN
Last Update Posted:
2020-04-30
First Post:
2020-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interstitial Lung Diseases Cohort Study in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, BALF, lung tissue, fibroblast'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Database and biological sample library for Chinese patients with interstitial lung disease', 'timeFrame': 'up to 4 years', 'description': 'Data analyses will be mainly descriptive.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '40967367', 'type': 'DERIVED', 'citation': 'Wang H, Liu A, Ni Y, Wang J, Du J, Xi L, Qiang Y, Xie B, Ren Y, Wang S, Geng J, Deng Y, Huang S, Zhang R, Liu M, Dai H; China Interstitial Lung Disease Collaboration Network. Developing and Validation of a Multimodal-Based Machine Learning Model for Diagnosis of Usual Interstitial Pneumonia: A Prospective Multicenter Study. Chest. 2025 Sep 16:S0012-3692(25)05248-1. doi: 10.1016/j.chest.2025.08.034. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'In this project, the clinical diagnosis of interstitial lung diseases was carried out for the population with suspected interstitial lung diseases selected from the community cohort, and the confirmed patients were included into the existing clinical cohort of interstitial lung diseases, forming an interstitial lung diseases special disease cohort consisting of 3,000 patients and corresponding matched control groups. According to characteristics of interstitial lung disease and the needs of National Key R\\&D Program of China, this study will formulate unified clinical follow-up strategy to do long-term standardized clinical follow-up in patients with interstitial lung disease. The detailed information for clinical diagnosis and treatment as well as biological samples were collected to identify disease phenotype and build the database and biological sample library for interstitial lung disease cohort study. This study aims to provide evidence for molecular classification, screening and validation of biomarkers as well as precise diagnosis and prevention in patients with interstitial lung disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the hospitals involved in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosed IPF during the last 3 months based upon ATS/ERS/JRS/ALAT guidelines 2011\n* Agree to sign the informed consent\n\nExclusion Criteria:\n\n* Lung transplantation expected within the next 6 months'}, 'identificationModule': {'nctId': 'NCT04370158', 'acronym': 'ILD-China', 'briefTitle': 'Interstitial Lung Diseases Cohort Study in China', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Interstitial Lung Diseases Cohort Study in China', 'orgStudyIdInfo': {'id': 'ChinaJapanFH003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'disease history', 'type': 'OTHER', 'description': 'Clinical progression and prognosis of patients with interstitial lung diseases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dai Huaping', 'role': 'CONTACT', 'email': 'daihuaping@sina.com', 'phone': '0086-10-84206271'}], 'facility': 'Huaping Dai', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'The Fourth Affiliated Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Center for Respiratory Diseases', 'investigatorFullName': 'Dai Huaping', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}