Interstitial Lung DiseaseNCT03478826
Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
An observational study of Interstitial Lung Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- ILD, Healthy and Pneumonia
- How many people
- 635 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to Jan 2028
- 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: Patients with a diagnosis of ILD or any fibrotic disease of the lung. A diagnosis of pneumonia and healthy volunteers will also be included as a control group.
Who may be able to join
- Patients with a diagnosis of ILD or any fibrotic disease of the lung or a diagnosis of pneumonia
- Patients willing to provide written informed consent
Who cannot join
- Unwillingness/unable to give blood samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Michael Stachowitz, 507-284-4862, Stachowitz.Michael@mayo.edu
Eva Carmona, M.D., Ph.D.
About this study
To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group.
Read the detailed description
The proposed biospecimen repository would be derived from patients diagnosed with ILD. This is to include 500 patients in the repository, with each patient contributing one blood sample. Patients with pneumonia and healthy patients will also be recruited as a control group.
- Conditions
- Interstitial Lung Disease
- Being tested
- ILD, Healthy, Pneumonia
- Keywords
- ILD
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILDOther
100 cc of blood collected from a total of 250 ILD patients. This includes IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20)), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis
HealthyOther
100 cc of blood collected from a total of 25 healthy volunteers in order to compare with the ILD participants.
PneumoniaOther
100 cc of blood collected from a total of 100 participants with a diagnosis of pneumonia in order to compare with the ILD participants.
| Study group | Role | What they receive |
|---|---|---|
| ILD | 250 patients (male and females >18 years of age) with the diagnosis of fibrotic DILD (IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis. Receives: Other: ILD | |
| Healthy | 100 healthy participants as a control group. Receives: Other: Healthy | |
| Pneumonia | 25 patients with pneumonia as a control group. Receives: Other: Pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Future Disease Management
Reliable biomarkers to help guide treatment in ILD would be a major step forward in the management of this disease.
Measured: 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Aug 2018
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 635 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva M. Carmona Porquera, Mayo Clinic
- Investigators
- Eva M Carmona Porquera, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478826
- Sponsor's protocol ID
- 17-008088
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2018
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared at this time, but it may be possible that in the future outside institutions or other researchers within the Mayo Clinic may ask for specimen samples. If a specimen sample is requested, a new protocol will be submitted to the IRB or the IRB application for this study will be amended.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
- ClinicalTrials.gov ID
- NCT03478826
- Acronym / sponsor ID
- 17-008088
- Conditions
- Interstitial Lung Disease
- Keywords
- ILD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 635 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 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.
To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group.
Detailed description
The proposed biospecimen repository would be derived from patients diagnosed with ILD. This is to include 500 patients in the repository, with each patient contributing one blood sample. Patients with pneumonia and healthy patients will also be recruited as a control group.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ILD | – | Other: ILD250 patients (male and females >18 years of age) with the diagnosis of fibrotic DILD (IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis. |
| Healthy | – | Other: Healthy100 healthy participants as a control group. |
| Pneumonia | – | Other: Pneumonia25 patients with pneumonia as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of ILD or any fibrotic disease of the lung. A diagnosis of pneumonia and healthy volunteers will also be included as a control group.
Key inclusion criteria (2 listed)
- Patients with a diagnosis of ILD or any fibrotic disease of the lung or a diagnosis of pneumonia
- Patients willing to provide written informed consent
Key exclusion criteria (1 listed)
- Unwillingness/unable to give blood samples
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 |
|---|---|---|
| ILD100 cc of blood collected from a total of 250 ILD patients. This includes IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20)), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis | Other | ILD |
| Healthy100 cc of blood collected from a total of 25 healthy volunteers in order to compare with the ILD participants. | Other | Healthy |
| Pneumonia100 cc of blood collected from a total of 100 participants with a diagnosis of pneumonia in order to compare with the ILD participants. | Other | Pneumonia |
Primary outcome
Future Disease Management
Time frame: 1 visit
Reliable biomarkers to help guide treatment in ILD would be a major step forward in the management of this disease.
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 Apr 2026.
- Individual participant dataSharing planned: No. IPD will not be shared at this time, but it may be possible that in the future outside institutions or other researchers within the Mayo Clinic may ask for specimen samples. If a specimen sample is requested, a new protocol will be submitted to the IRB or the IRB application for this study will be amended.
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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.
Eva M Carmona Porquera, MD, PhD principal investigator
Mayo Clinic
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 Interstitial Lung Disease, run by Mayo Clinic 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 1 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
Contact Michael Stachowitz (507-284-4862, Stachowitz.Michael@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Future Disease Management (time frame: 1 visit). 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 Apr 2026.