Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT03711435
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2018-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and Metabolomics
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2018-10-07', 'studyFirstSubmitQcDate': '2018-10-17', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biomarkers detected in metabolites', 'timeFrame': '1 year', 'description': 'Metabolomics of serum based on mass spectrometry.It is non-targeted metabolomics.The study is to find the target metabolite to distinguish IPF.'}], 'secondaryOutcomes': [{'measure': 'High-resolution chest CT total score (CT-Tot)', 'timeFrame': '1 year', 'description': 'High-resolution chest CT total score (CT-Tot), which includes the grid shadow and the honeycomb lung. The score range is 0-5, and the larger the score, the more serious the disease.'}, {'measure': 'Six Minute Walk Test(6MWT)', 'timeFrame': '1 year', 'description': 'The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.It is a simple objective indicator for evaluating cardiopulmonary function'}, {'measure': 'Pulmonary function Pulmonary function', 'timeFrame': '1 year', 'description': 'Pulmonary function including forced vital capacity(FVC),forced expiratory volume at one second(FEV1),diffusion capacity of lung for carbon monoxide(DLCO)'}, {'measure': "St. George's Respiratory Questionnaire", 'timeFrame': '1 year', 'description': "St. George's Respiratory Questionnaire is measuring impaired health and perceived well-being ('quality of life') in airways disease. the score is 0 to 100，the higher the score is，the worse life quality the patients has."}]}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'Metabolomics', 'Chinese medicine'], 'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'The pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no specific biomarkers, the treatment effect is not such useful. Currently, it is discovered that Chinese medicine treatment may be effective. The investigators select patients with idiopathic pulmonary interstitial fibrosis and healthy controls, use metabolomics to study the biological characteristics of idiopathic pulmonary interstitial fibrosis, screen biomarkers of IPF, and label different TCM syndromes of IPF, explore the biological nature of IPF TCM syndromes, find the biological changes that occur during the development and progression of IPF and explore the metabolite marker clusters of IPF. Furthermore, the results of this study may find its diagnostic significance for IPF and Looking for potential targets for future treatment of IPF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IPF patients in XUZHOU', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case group inclusion criteria\n\n 1. According to the diagnostic criteria published in 2015, the New Guidelines for the Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis, jointly developed by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Society;\n 2. aged 50 to 85 years old;\n\nControl group inclusion criteria:\n\nHealth people match on the age (±3 years old) and gender with case group with 1:1 rate at the same time.\n\nExclusion Criteria:\n\n* Case group exclusion criteria:\n\n 1. Those with severe heart, liver, kidney and other organ dysfunction or suffering from blood diseases;\n 2. with malignant tumors;\n 3. Severely infected people;\n 4. Pregnant and lactating women;\n 5. mental illness, serious obstacles and those who are unwilling to cooperate;\n\nControl group exclusion criteria:\n\n1. Those with severe heart, liver, kidney and other organ dysfunction or blood disease;\n2. With malignant tumors;\n3. Chest X-ray or chest low-dose CT suggesting intra-pulmonary interstitial fibrosis;\n4. With chronic pulmonary diseases such as pulmonary interstitial disease, chronic obstructive pulmonary disease, and bronchial asthma;\n5. With connective tissue disease and those with a history of exposure to occupational diseases;\n6. Mental illness, serious obstacles and unwilling to cooperate.'}, 'identificationModule': {'nctId': 'NCT03711435', 'briefTitle': 'Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and Metabolomics', 'organization': {'class': 'OTHER', 'fullName': 'Xuzhou Traditional Chinese Medicine Hospital'}, 'officialTitle': 'Study on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on Metabolomics', 'orgStudyIdInfo': {'id': 'XZTCM2018LSY-013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training set', 'description': 'The training set is composed of 30 IPF patients and 15 controls. The group is designed to identify differential metabolites between IPF and control groups.'}, {'label': 'Validation set', 'description': 'The validation set is composed of 15 IPF patients and 15 controls. The group is designed to validate differential metabolites identified in the previous groups.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Xuzhou Traditional Chinese Medicine Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'overallOfficials': [{'name': 'YING MS ZHAO, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuzhou Traditional Chinese Medicine Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Other researchers may contact us with email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuzhou Traditional Chinese Medicine Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}