Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-02-03 @ 8:57 AM
Study NCT ID:
NCT02151435
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2014-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Biomarker Profiles in 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood plasma obtained from individuals at 6-month intervals for up to 2 years'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2014-05-28', 'studyFirstSubmitQcDate': '2014-05-29', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Longitudinal change in biomarker levels', 'timeFrame': '1 year', 'description': 'In exploratory analyses, longitudinal change in your biomarker expression will be correlated with your disease progression to determine if change in biomarker levels over time predict subsequent disease progression.'}], 'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '1 year', 'description': 'The primary outcome is your progression free survival as determined by time until any of: death, acute exacerbation of IPF, relative decline in FVC (liters) of at least 10% or DLCO (ml/min/mmHg) of 15% from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'Biomarkers', 'Forced Vital Capacity', 'Diffusion Capacity for Carbon Monoxide', 'Prognosis'], 'conditions': ['IPF']}, 'descriptionModule': {'briefSummary': 'Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung. The estimated prevalence is 30-80/100,000 in the United States with incidence estimates clearly rising. A major challenge in the care of patients with IPF is determining prognosis. The natural history of IPF is usually one of inexorable decline in lung function, ultimately resulting in death from respiratory failure. However, longitudinal physiologic decline in IPF is heterogeneous and difficult to predict in individual patients. While some patients with IPF may remain stable for years, in others the disease may progress rapidly over a relatively short time. We hypothesize that peripheral blood biomarkers based on extracellular matrix and matrix-modifying molecules will improve prognostication in patients with IPF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes subjects with IPF identified via the University of Michigan Interstitial Lung Disease Clinical-Radiologic-Pathologic Conference. The investigators will only enroll subjects in whom an IPF diagnosis is firmly established.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 35-80 years, inclusive\n2. Diagnosis of IPF by HRCT or surgical lung biopsy\n3. Able to understand and provide informed consent\n\nExclusion Criteria:\n\n1. AE-IPF during the prior year\n2. Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease.\n3. Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria.\n4. Significant airway obstruction (FEV1/FVC ratio \\< 0.60) or bronchodilator response, defined as a change in FEV1 ≥ 12% and absolute change \\> 200 mL OR change in FVC ≥ 12% and absolute change \\> 200 mL at baseline\n5. Partial pressure of arterial oxygen (PaO2) \\< 55 mm Hg\n6. Evidence of active infection\n7. Listed for lung transplantation\n8. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months\n9. Unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months\n10. Uncontrolled arrhythmia or hypertension\n11. Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis\n12. Active substance and/or alcohol abuse\n13. If you are pregnant or breastfeeding\n14. Any condition other than IPF that is likely to result in your death within the next year\n15. Any condition that, in the judgment of the PI, might cause participation in the study to be detrimental to you or that the PI deems makes you a poor candidate'}, 'identificationModule': {'nctId': 'NCT02151435', 'briefTitle': 'Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'UM HUM00004076'}, 'secondaryIdInfos': [{'id': 'R01HL109118', 'link': 'https://reporter.nih.gov/quickSearch/R01HL109118', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with IPF', 'description': 'Observation of longitudinal biomarkers in IPF patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Eric S White, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine', 'investigatorFullName': 'Eric S. White, MD', 'investigatorAffiliation': 'University of Michigan'}}}}