Idiopathic Pulmonary FibrosisNCT02407431
PaTH Clinical Data Research Network (CDRN) Idiopathic Pulmonary Fibrosis (IPF) Clinician Patient Partnership Cohort
An observational study of Idiopathic Pulmonary Fibrosis, run by University of Pittsburgh at 5 sites in United States.
Trial summary
The purpose of the PaTH Network IPF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients with Idiopathic Pulmonary Fibrosis, providers, and other stakeholders. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 1,000 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2015to Jul 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target study population is adults with IPF who receive health care at one of the PaTH Network institutions.
Who may be able to join
- The target study population is adults identified as having IPF (through the PaTH IPF computable phenotype algorithm or a local IPF registry).
Who cannot join
- Age <18 years
- Deceased
- Not proficient in English
- Has not had at least one outpatient encounter in the past 18 months at the PaTH health system's pulmonary specialty clinic through which they are recruited
- Lung transplant
- Already enrolled in the PaTH Clinician-Patient Partnership Cohort at another PaTH institution
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21231
Jody McCullough
Hershey, Pennsylvania, 17033
Anuradha Paranjape
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Utah
Salt Lake City, Utah, 84108
About this study
The purpose of the PaTH Network IPF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients with Idiopathic Pulmonary Fibrosis, providers, and other stakeholders.
Read the detailed description
The primary objective is to create the PaTH Network IPF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on IPF across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network. Creating the IPF Clinician-Patient Partnership Cohort will involve:
- Recruiting patients with IPF to participate in the PaTH Network IPF Clinician-Patient Partnership Cohort
- Administering surveys to the IPF Clinician-Patient Partnership Cohort approximately every 3 months to collect patient reported outcomes (PROs)
- Merging individual patient health record data into the IPF Clinician-Patient Partnership Cohort database
- Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.
- Determining if an automated procedure for identifying duplicate patients across PaTH institutions without the use of protected health information (PHI) is valid compared to a manual matching procedure using PHI.
- Identifying potential participants for future research studies.
The secondary objectives are to use the PaTH Network IPF Clinician-Patient Partnership Cohort to answer patient-centered research questions including:
- What is the prevalence of gastroesophageal reflux disease (GERD) in IPF, and what effect does GERD and its treatment have on IPF disease progression, quality of life, and survival?
- What is the association of oxygen use with survival, quality of life, exercise tolerance, neurocognitive function, and dyspnea?
- How often do IPF patients have advance directives, how often are advance directives documented in the electronic health record, and does having an advance directive influence how/where IPF patients die, their health care utilization, satisfaction with care, and quality of life?
- Conditions
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Create PaTH Network IPF Clinician-Patient Partnership Cohort
Create the PaTH Network IPF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on IPF across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Johns Hopkins University, Penn State University, University of Utah
- Responsible party
- Principal investigator, Kathleen McTigue, University of Pittsburgh
- Investigators
- Kathleen McTigue, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407431
- Sponsor's protocol ID
- STUDY20110299
- Other IDs
- CDRN-1306-04912
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2015
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PaTH Clinical Data Research Network (CDRN) Idiopathic Pulmonary Fibrosis (IPF) Clinician Patient Partnership Cohort
- ClinicalTrials.gov ID
- NCT02407431
- Acronym / sponsor ID
- STUDY20110299
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Temple University, Johns Hopkins University, Penn State University, University of Utah
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 3 Apr 2015 (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.
The purpose of the PaTH Network IPF Clinician-Patient Partnership Cohort is to use clinical data from electronic health records (EHR) and patient reported outcomes (PRO) to answer questions of clinical importance to patients with Idiopathic Pulmonary Fibrosis, providers, and other stakeholders.
Detailed description
The primary objective is to create the PaTH Network IPF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on IPF across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network. Creating the IPF Clinician-Patient Partnership Cohort will involve:
- Recruiting patients with IPF to participate in the PaTH Network IPF Clinician-Patient Partnership Cohort
- Administering surveys to the IPF Clinician-Patient Partnership Cohort approximately every 3 months to collect patient reported outcomes (PROs)
- Merging individual patient health record data into the IPF Clinician-Patient Partnership Cohort database
- Tracking whether the patient participant has biospecimens in a PaTH site biorepository and prepare for possible sharing of biospecimens in future studies.
- Determining if an automated procedure for identifying duplicate patients across PaTH institutions without the use of protected health information (PHI) is valid compared to a manual matching procedure using PHI.
- Identifying potential participants for future research studies.
The secondary objectives are to use the PaTH Network IPF Clinician-Patient Partnership Cohort to answer patient-centered research questions including:
- What is the prevalence of gastroesophageal reflux disease (GERD) in IPF, and what effect does GERD and its treatment have on IPF disease progression, quality of life, and survival?
- What is the association of oxygen use with survival, quality of life, exercise tolerance, neurocognitive function, and dyspnea?
- How often do IPF patients have advance directives, how often are advance directives documented in the electronic health record, and does having an advance directive influence how/where IPF patients die, their health care utilization, satisfaction with care, and quality of life?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target study population is adults with IPF who receive health care at one of the PaTH Network institutions.
Key inclusion criteria (1 listed)
- The target study population is adults identified as having IPF (through the PaTH IPF computable phenotype algorithm or a local IPF registry).
Key exclusion criteria (6 listed)
- Age <18 years
- Deceased
- Not proficient in English
- Has not had at least one outpatient encounter in the past 18 months at the PaTH health system's pulmonary specialty clinic through which they are recruited
- Lung transplant
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
Create PaTH Network IPF Clinician-Patient Partnership Cohort
Time frame: 18 months
Create the PaTH Network IPF Clinician-Patient Partnership Cohort, which will allow the conduct of patient-centered observational studies on IPF across the multiple institutions (Hershey Penn State, University of Pittsburgh, Temple University) of the PaTH network.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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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.
Kathleen McTigue, MD principal investigator
University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by University of Pittsburgh at 5 sites 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Create PaTH Network IPF Clinician-Patient Partnership Cohort (time frame: 18 months). 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 3 Sep 2026.