Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-01 @ 10:29 PM
Study NCT ID:
NCT06275295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-17', 'studyFirstSubmitDate': '2024-02-17', 'studyFirstSubmitQcDate': '2024-02-17', 'lastUpdatePostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic rate of MDD2 based on TBLC', 'timeFrame': 'December，31，2024', 'description': 'the diagnostic rate of progressive pulmonary fibrosis after Transbronchial Cryobiopsy'}], 'secondaryOutcomes': [{'measure': 'The diagnostic rate of MDD1', 'timeFrame': 'December，31，2024', 'description': 'the diagnostic rate of progressive pulmonary fibrosis before Transbronchial Cryobiopsy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis', 'Transbronchial Cryobiopsy']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis.', 'detailedDescription': "The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis. The main question it aims to answer are: • The diagnostic rate of MDD1 or MDD2 based on TBLC. • The rate of hemorrhage, pneumothorax, acute ILD exacerbation and mortality. Participants' medical records will be collected by us."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving TBLC for progressive pulmonary fibrosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with PPF, ≥18 years of age, unclassified ILD, HRCT ≤3 months, forced vital capacity (FVC)≥50% predicted value, pulmonary carbon monoxide diffusion (DLCO)≥35% predicted value, echocardiography ≤12 months, estimated pulmonary systolic blood pressure ≤40 mmHg, Body mass index (BMI)≤35 kg/m2.\n\nExclusion Criteria:\n\nPatients with platelet counts below 50,000e+9/L or International Normalized ratio of prothrombin time (INR) above 1.5 are not eligible for TBLC'}, 'identificationModule': {'nctId': 'NCT06275295', 'briefTitle': 'A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis：a Multicenter Retrospective Study', 'orgStudyIdInfo': {'id': 'ZRJY2021-BJ08-03-01-01'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gang Hou, Professor', 'role': 'CONTACT', 'email': 'hougangcmu@163.com', 'phone': '1384005481'}, {'name': 'Mingming Deng, PhD', 'role': 'CONTACT', 'email': 'isdeng@163.com', 'phone': '+86 18801336854'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gang Hou', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}