Idiopathic Pulmonary FibrosisNCT03457935
Detection of Early Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis, run by Temple University at 1 site in United States.
Trial summary
The purpose of the study is to determine if miR200 family may serve as a biomarker of IPF. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- blood samples
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 30 Aug 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with non-IPF ILD and a new diagnosis of IPF.
Who may be able to join
- Informed consent
- Subjects ≥ 40 y.o.
- Naive patients with no IPF treatment
- IPF diagnosis based on the ATS/ERS/JRS/ALAT criteria
- Informed consent
- Subjects ≥ 18 y.o.
- ILD diagnosis
Who cannot join
- HIV
- Hepatitis B
- Hepatitis C
- Pregnant or lactating women
- inclusion criteria for controls: informed consent >18 years old; no lung diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the miR200 Family in the Restoration of Normal Lung Homeostasis and Detection of Early IPF
The purpose of the study is to determine if miR200 family may serve as a biomarker of IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- blood samples
- 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.
blood samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Non-IPF ILD | non-IPF ILD diagnosis Receives: Other: blood samples | |
| IPF | Naive patients with no IPF treatment Receives: Other: blood samples | |
| Control | no lung diseases Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine miR200 levels (fold change) in blood samples.
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.
Measured: Baseline (one time).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start10 Apr 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Aug 2026 (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.
- 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457935
- Sponsor's protocol ID
- 23201
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2018
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the miR200 Family in the Restoration of Normal Lung Homeostasis and Detection of Early IPF
- ClinicalTrials.gov ID
- NCT03457935
- Acronym / sponsor ID
- 23201
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 8 Mar 2018 (actual)
- 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 study is to determine if miR200 family may serve as a biomarker of IPF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-IPF ILD | – | Other: blood samplesnon-IPF ILD diagnosis |
| IPF | – | Other: blood samplesNaive patients with no IPF treatment |
| Control | – | Other: blood samplesno lung diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with non-IPF ILD and a new diagnosis of IPF.
Key inclusion criteria (7 listed)
- Informed consent
- Subjects ≥ 40 y.o.
- Naive patients with no IPF treatment
- IPF diagnosis based on the ATS/ERS/JRS/ALAT criteria
- Informed consent
Key exclusion criteria (5 listed)
- HIV
- Hepatitis B
- Hepatitis C
- Pregnant or lactating women
- inclusion criteria for controls: informed consent >18 years old; no lung diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplesBlood samples | Other | Control, IPF, Non-IPF ILD |
Primary outcome
To determine miR200 levels (fold change) in blood samples.
Time frame: Baseline (one time).
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.
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 29 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Temple University 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 7 inclusion and 5 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 29 Dec 2025. 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?
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?
To determine miR200 levels (fold change) in blood samples. (time frame: Baseline (one time).). 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 29 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.