Chronic Obstructive Pulmonary DiseaseLTRCNCT02988388
Lung Tissue Research Consortium
An observational study of Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 4 sites in United States.
Trial summary
The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the LTRC. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- What is being tested?
- Lung biopsy/lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 247 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Feb 2017to 21 Feb 2019
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
Who may be able to join
- Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
Who cannot join
- Diagnosis of cystic fibrosis or pulmonary hypertension.
- Any other condition that, in the judgment of the investigator, precludes participation.
- Failure to obtain written consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 14213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the LTRC. Collections of specimens will be linked to individual clinical data appropriate to the particular disease. The primary goal of the LTRC is to identify participants with suspected lung cancer or metastatic disease who are willing to provide informed consent for research use of their specimens and data. Secondarily, the LTRC investigators intend to collect clinical data, limited exposure data, physiologic studies, and radiographic studies from these participants.
- Being tested
- Lung biopsy/lobectomy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung biopsy/lobectomyProcedure or surgery
Lung biopsies and lobectomies are not experimental. Participants will undergo a lung biopsy or a lobectomy as part of standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Lung biopsy/lobectomy | Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases. Receives: Procedure: Lung biopsy/lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical diagnosis
A final diagnosis of the participant's lung disease will be rendered by the clinical center PI.
Measured: Two months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start23 Feb 2017
- Primary completion28 Jan 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tom Croxton, Study director, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988388
- Sponsor's protocol ID
- LTR01
- Acronym
- LTRC
- Status last verified
- Aug 2017
- First submitted
- 7 Dec 2016
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may submit an application for access to LTRC participant data including clinical and pathological diagnoses, radiological images (CT scans) and diagnoses, environmental and occupational exposure questionnaires, respiratory questionnaires and assessments, pulmonary function testing, concomitant therapy, medical history, smoking history, and laboratory measures. Gene array data are also available for a subset of participants. All data are de-identified. No protected health information is released to researchers external to LTRC.
Publications
Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
PubMed 35688625
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Tissue Research Consortium
- ClinicalTrials.gov ID
- NCT02988388
- Acronym / sponsor ID
- LTRC / LTR01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 9 Dec 2016 (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 LTRC will facilitate histopathological research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the LTRC. Collections of specimens will be linked to individual clinical data appropriate to the particular disease. The primary goal of the LTRC is to identify participants with suspected lung cancer or metastatic disease who are willing to provide informed consent for research use of their specimens and data. Secondarily, the LTRC investigators intend to collect clinical data, limited exposure data, physiologic studies, and radiographic studies from these participants.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung biopsy/lobectomy | – | Procedure: Lung biopsy/lobectomyAdults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
Key inclusion criteria (1 listed)
- Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.
Key exclusion criteria (3 listed)
- Diagnosis of cystic fibrosis or pulmonary hypertension.
- Any other condition that, in the judgment of the investigator, precludes participation.
- Failure to obtain written consent.
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 |
|---|---|---|
| Lung biopsy/lobectomyLung biopsies and lobectomies are not experimental. Participants will undergo a lung biopsy or a lobectomy as part of standard of care. | Procedure or surgery | Lung biopsy/lobectomy |
Primary outcome
Clinical diagnosis
Time frame: Two months following surgery
A final diagnosis of the participant's lung disease will be rendered by the clinical center PI.
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 8 Mar 2019.
- Derived from this study: PubMed 35688625Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
- Individual participant dataSharing planned: Yes. Qualified researchers may submit an application for access to LTRC participant data including clinical and pathological diagnoses, radiological images (CT scans) and diagnoses, environmental and occupational exposure questionnaires, respiratory questionnaires and assessments, pulmonary function testing, concomitant therapy, medical history, smoking history, and laboratory measures. Gene array data are also available for a subset of participants. All data are de-identified. No protected health information is released to researchers external to LTRC.
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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.
Tom Croxton study director
National Heart, Lung, and Blood Institute (NHLBI)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 4 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 3 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Clinical diagnosis (time frame: Two months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988388, which also lists 1 linked publication.
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 8 Mar 2019.