Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT03457935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2018-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Early Idiopathic Pulmonary Fibrosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2018-02-28', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine miR200 levels (fold change) in blood samples.', 'timeFrame': 'Baseline (one time).', 'description': 'MicroRNAs (miRs) are noncoding small RNAs, which regulate numerous physiological and pathological processes. miR200 levels will be measured in blood samples collected from control subjects, non-IPF ILD and IPF patients. These samples will be used for identifying biomarkers for IPF.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if miR200 family may serve as a biomarker of IPF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with non-IPF ILD and a new diagnosis of IPF.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for IPF Patients:\n\n* Informed consent\n* Subjects ≥ 40 y.o.\n* Naive patients with no IPF treatment\n* IPF diagnosis based on the ATS/ERS/JRS/ALAT criteria\n\nInclusion Criteria for non-IPF ILD Patients:\n\n* Informed consent\n* Subjects ≥ 18 y.o.\n* ILD diagnosis\n\nExclusion Criteria:\n\n* HIV\n* Hepatitis B\n* Hepatitis C\n* Pregnant or lactating women\n\ninclusion criteria for controls: informed consent \\>18 years old; no lung diseases'}, 'identificationModule': {'nctId': 'NCT03457935', 'briefTitle': 'Detection of Early Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'The Role of the miR200 Family in the Restoration of Normal Lung Homeostasis and Detection of Early IPF', 'orgStudyIdInfo': {'id': '23201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-IPF ILD', 'description': 'non-IPF ILD diagnosis', 'interventionNames': ['Other: blood samples']}, {'label': 'IPF', 'description': 'Naive patients with no IPF treatment', 'interventionNames': ['Other: blood samples']}, {'label': 'Control', 'description': 'no lung diseases', 'interventionNames': ['Other: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'OTHER', 'description': 'Blood samples', 'armGroupLabels': ['Control', 'IPF', 'Non-IPF ILD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}