Idiopathic Pulmonary Fibrosis (IPF)NCT01718990
Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by University of California, San Francisco at 1 site in United States.
Trial summary
Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations. This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 31 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: IPF
Who may be able to join
- age 35 to 80 years
- a diagnosis of IPF by consensus criteria
Who cannot join
- any condition that makes the patient at unacceptable risk for bronchoscopy
- the presence of significant co-existing emphysema on HRCT
- active cigarette smoking (defined as smoking within the last 6 months)
- the presence of a significant co-morbidity felt to limit life expectancy to less than 12 months.
- active listing for lung transplantation
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Prospective, Longitudinal Cohort Trial of Patients With Idiopathic Pulmonary Fibrosis (IPF) and Healthy Control Patients. Clinical Data, Blood, and Bronchiolavage (BAL) Fluid Will be Collected Over 12 Months.
Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations.
This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. The people who have IPF will be followed for 12 months to collect more biological samples and record clinically relevant information.
The goal of this study is to identify new molecular markers that are measurable and reliable in people who have IPF. It is hoped that these markers can be used in future drug studies to significantly speed up the process of finding drugs that help.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- 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 Idiopathic Pulmonary Fibrosis (IPF) | Sixty patients with IPF will be included in this prospective cohort;15 IPF patients per year for years 1-4. | |
| Healthy Volunteers | Sixty normal controls will be recruited from volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Markers
We anticipate that we will successfully enroll 60 subjects with IPF in a 12 month longitudinal cohort study and provide biological samples (Bronchiolavage (BAL), alveolar macrophages, and blood) to Projects 1-3 for use in identifying mechanistically-informative markers of alveolar epithelial cell ER stress, αvβ6-mediated TGFβ activation, and EMT. We expect that levels of some of these mechanistic markers will be measurable in patient samples, and may be differentially present in IPF compared to normal controls. Variations in baseline levels of mechanistically-informative molecular markers may identify subgroups of Idiopathic Pulmonary Fibrosis (IPF) patients that share distinct clinical phenotypes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completion30 Jun 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold Collard, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718990
- Sponsor's protocol ID
- PPG-IPF
- Status last verified
- Jul 2020
- First submitted
- 29 Oct 2012
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Longitudinal Cohort Trial of Patients With Idiopathic Pulmonary Fibrosis (IPF) and Healthy Control Patients. Clinical Data, Blood, and Bronchiolavage (BAL) Fluid Will be Collected Over 12 Months.
- ClinicalTrials.gov ID
- NCT01718990
- Acronym / sponsor ID
- PPG-IPF
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Nov 2012 (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.
Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations.
This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. The people who have IPF will be followed for 12 months to collect more biological samples and record clinically relevant information.
The goal of this study is to identify new molecular markers that are measurable and reliable in people who have IPF. It is hoped that these markers can be used in future drug studies to significantly speed up the process of finding drugs that help.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Idiopathic Pulmonary Fibrosis (IPF) | – | –Sixty patients with IPF will be included in this prospective cohort;15 IPF patients per year for years 1-4. |
| Healthy Volunteers | – | –Sixty normal controls will be recruited from volunteers. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IPF
Key inclusion criteria (2 listed)
- age 35 to 80 years
- a diagnosis of IPF by consensus criteria
Key exclusion criteria (6 listed)
- any condition that makes the patient at unacceptable risk for bronchoscopy
- the presence of significant co-existing emphysema on HRCT
- active cigarette smoking (defined as smoking within the last 6 months)
- the presence of a significant co-morbidity felt to limit life expectancy to less than 12 months.
- active listing for lung transplantation
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
Molecular Markers
Time frame: 12 months
We anticipate that we will successfully enroll 60 subjects with IPF in a 12 month longitudinal cohort study and provide biological samples (Bronchiolavage (BAL), alveolar macrophages, and blood) to Projects 1-3 for use in identifying mechanistically-informative markers of alveolar epithelial cell ER stress, αvβ6-mediated TGFβ activation, and EMT. We expect that levels of some of these mechanistic markers will be measurable in patient samples, and may be differentially present in IPF compared to normal controls. Variations in baseline levels of mechanistically-informative molecular markers may identify subgroups of Idiopathic Pulmonary Fibrosis (IPF) patients that share distinct clinical phenotypes.
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 31 Jul 2020.
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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.
Harold Collard, MD principal investigator
University of California, San Francisco
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 Idiopathic Pulmonary Fibrosis (IPF), run by University of California, San Francisco 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 2 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: finished, as of the sponsor's last update on 31 Jul 2020. 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?
Molecular Markers (time frame: 12 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 31 Jul 2020.