IPFNCT02151435
Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis
An observational study of IPF, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- IPF
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 35-80 years, inclusive
- Diagnosis of IPF by HRCT or surgical lung biopsy
- Able to understand and provide informed consent
Who cannot join
- AE-IPF during the prior year
- Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease.
- Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria.
- 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
- Partial pressure of arterial oxygen (PaO2) < 55 mm Hg
- Evidence of active infection
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- Listed for lung transplantation
- Myocardial infarction, coronary artery bypass, or angioplasty within 6 months
- Unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months
- Uncontrolled arrhythmia or hypertension
- Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis
- Active substance and/or alcohol abuse
- If you are pregnant or breastfeeding
- Any condition other than IPF that is likely to result in your death within the next year
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- IPF
- Keywords
- Idiopathic Pulmonary Fibrosis, Biomarkers, Forced Vital Capacity, Diffusion Capacity for Carbon Monoxide, Prognosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IPF | Observation of longitudinal biomarkers in IPF patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric S. White, MD, University of Michigan
- Investigators
- Eric S White, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151435
- Sponsor's protocol ID
- UM HUM00004076
- Other IDs
- R01HL109118
- Status last verified
- Jul 2017
- First submitted
- 28 May 2014
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02151435
- Acronym / sponsor ID
- UM HUM00004076
- Conditions
- IPF
- Keywords
- Idiopathic Pulmonary Fibrosis, Biomarkers, Forced Vital Capacity, Diffusion Capacity for Carbon Monoxide, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Brown University
- Study start
- Aug 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IPF | – | –Observation of longitudinal biomarkers in IPF patients |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age 35-80 years, inclusive
- Diagnosis of IPF by HRCT or surgical lung biopsy
- Able to understand and provide informed consent
Key exclusion criteria (15 listed)
- AE-IPF during the prior year
- Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease.
- Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria.
- 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
- Partial pressure of arterial oxygen (PaO2) < 55 mm Hg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric S White, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IPF, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.