Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research (ALD Biobank)

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Respiratory Failure; Interstitial Lung Disease
• Intervention / Treatment: Other: Patient Biospecimen Registry (observational and blood sampling)

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Susan Mathai, MD; Phone Number: 214-820-6856; Email: Susan.Mathai@bswhealth.org
• Study Contact Backup: Name: Tammy Fischer; Email: Tammy.Fisher@BSWHealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White Research Institute
      • Principal Investigator: Susan Mathai, MD
      • Contact: Brianna Kamran; Phone Number: 214-820-1685; Email: brianna.kamran@bswhealth.org
      • Contact: Felicia Padilla, MPH; Phone Number: 214-820-1771; Email: Felicia.Padilla@BSWHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Lung transplant recipients

Description

Inclusion Criteria:

1. All individuals aged 18 years and older
2. Persons who have undergone lung transplantation at Baylor University Medical Center in the previous 10 years
3. Individual is able to understand and sign the informed consent form

Exclusion Criteria:

1. Significant documented anemia (hemoglobin <8 g/dL)
2. Blood transfusions within past 3 weeks
3. Active cancer (non-skin cancers)
4. Enrollment against doctor recommendation
5. Patient not able to provide informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung transplant Recipients; Biobank registry for Lung transplant recipients	Other: Patient Biospecimen Registry (observational and blood sampling); Clinical data collected at every blood sample collection visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of patients with lung transplant	ICD 10 code for underlying lung disease	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Date of death	5 years

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Susan Mathai, MD, Baylor Scott & White Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Lung Diseases, Interstitial; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 021-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No