Respiratory FailureALD BiobankNCT04664192
Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research
An observational study of Respiratory Failure and Interstitial Lung Disease, run by Baylor Research Institute at 1 site in United States.
Trial summary
A major goal of this protocol is to support biomarker studies in advanced lung diseases, lung transplantation care, and to improve our understanding of the effects of viral and other infectious exposures to outcomes in our lung transplant and ALD patient populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Interstitial Lung Disease, Lung Diseases
- What is being tested?
- Patient Biospecimen Registry (observational and blood sampling)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2021to 1 Jan 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant recipients
Who may be able to join
- All individuals aged 18 years and older
- Persons who have undergone lung transplantation at Baylor University Medical Center in the previous 10 years
- Individual is able to understand and sign the informed consent form
Who cannot join
- Significant documented anemia (hemoglobin <8 g/dL)
- Blood transfusions within past 3 weeks
- Active cancer (non-skin cancers)
- Enrollment against doctor recommendation
- Patient not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Research Institute
Dallas, Texas, 75246
About this study
A major goal of this protocol is to support biomarker studies in advanced lung diseases, lung transplantation care, and to improve our understanding of the effects of viral and other infectious exposures to outcomes in our lung transplant and ALD patient populations.
Read the detailed description
The identification of biomarkers in a patient's blood or tissue that are specific for particular medical conditions (such as interstitial lung disease, chronic obstructive lung disease (COPD), and post-lung transplant rejection) is important for the prevention and early detection of the disease, as well as to advance our understanding of targeted therapies. Availability of biomarkers for diagnosis and for the prediction of patient prognosis and therapy promises personalized medicine. Patients may be selected based on the presence of particular gene mutations or circulating protein levels to receive personalized treatment. Furthermore, knowledge regarding genetic risk and susceptibility to infectious diseases as well as structural lung disease is rapidly growing-as whole genome sequencing and genome-wide association studies have become easier to do, genetic risk has emerged as increasingly important in understanding why and how some patients develop chronic lung disease. This is true for the spectrum of lung diseases treated in the ALD program, from those with airways diseases such as COPD to diffuse parenchymal lung diseases such as idiopathic pulmonary fibrosis (IPF). The availability of human biological specimens for research purposes is crucial for the advancement of medical knowledge of understanding, diagnosing, and treating chronic lung diseases and optimizing post-lung transplant care.
- Being tested
- Patient Biospecimen Registry (observational and blood sampling)
- Medical subject headings
- Respiratory Insufficiency, Lung Diseases, Interstitial, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Biospecimen Registry (observational and blood sampling)Other
Clinical data collected at every blood sample collection visit.
| Study group | Role | What they receive |
|---|---|---|
| Lung transplant Recipients | Biobank registry for Lung transplant recipients Receives: Other: Patient Biospecimen Registry (observational and blood sampling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of patients with lung transplant
ICD 10 code for underlying lung disease
Measured: 5 years
Secondary outcomes (1)
Survival
Date of death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start4 Jun 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Mathai, Baylor Research Institute
- Investigators
- Susan Mathai, MD, Principal investigator, Baylor Scott & White Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664192
- Sponsor's protocol ID
- 021-007
- Acronym
- ALD Biobank
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2020
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research
- ClinicalTrials.gov ID
- NCT04664192
- Acronym / sponsor ID
- ALD Biobank / 021-007
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Dec 2020 (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.
A major goal of this protocol is to support biomarker studies in advanced lung diseases, lung transplantation care, and to improve our understanding of the effects of viral and other infectious exposures to outcomes in our lung transplant and ALD patient populations.
Detailed description
The identification of biomarkers in a patient's blood or tissue that are specific for particular medical conditions (such as interstitial lung disease, chronic obstructive lung disease (COPD), and post-lung transplant rejection) is important for the prevention and early detection of the disease, as well as to advance our understanding of targeted therapies. Availability of biomarkers for diagnosis and for the prediction of patient prognosis and therapy promises personalized medicine. Patients may be selected based on the presence of particular gene mutations or circulating protein levels to receive personalized treatment. Furthermore, knowledge regarding genetic risk and susceptibility to infectious diseases as well as structural lung disease is rapidly growing-as whole genome sequencing and genome-wide association studies have become easier to do, genetic risk has emerged as increasingly important in understanding why and how some patients develop chronic lung disease. This is true for the spectrum of lung diseases treated in the ALD program, from those with airways diseases such as COPD to diffuse parenchymal lung diseases such as idiopathic pulmonary fibrosis (IPF). The availability of human biological specimens for research purposes is crucial for the advancement of medical knowledge of understanding, diagnosing, and treating chronic lung diseases and optimizing post-lung transplant care.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant Recipients | – | Other: Patient Biospecimen Registry (observational and blood sampling)Biobank registry for Lung transplant recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant recipients
Key inclusion criteria (3 listed)
- All individuals aged 18 years and older
- Persons who have undergone lung transplantation at Baylor University Medical Center in the previous 10 years
- Individual is able to understand and sign the informed consent form
Key exclusion criteria (5 listed)
- Significant documented anemia (hemoglobin <8 g/dL)
- Blood transfusions within past 3 weeks
- Active cancer (non-skin cancers)
- Enrollment against doctor recommendation
- Patient not able to provide informed 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 |
|---|---|---|
| Patient Biospecimen Registry (observational and blood sampling)Clinical data collected at every blood sample collection visit. | Other | Lung transplant Recipients |
Primary outcome
Diagnosis of patients with lung transplant
Time frame: 5 years
ICD 10 code for underlying lung disease
1 secondary outcome
Survival
Time frame: 5 years
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Susan Mathai, MD principal investigator
Baylor Scott & White Research Institute
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 Respiratory Failure and Interstitial Lung Disease, run by Baylor Research Institute 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 3 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 13 Aug 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?
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?
Diagnosis of patients with lung transplant (time frame: 5 years). 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 13 Aug 2026.