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Recruiting

NCT Number: NCT04664192

Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Patient Biospecimen Registry (observational and blood sampling)

Other

Clinical data collected at every blood sample collection visit.

Primary outcomes

  1. Diagnosis of patients with lung transplant

    Time frame: 5 years

    ICD 10 code for underlying lung disease

Secondary outcomes

  1. Survival

    Time frame: 5 years

    Date of death

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Mathai, MD

CONTACT

[email protected]

214-820-6856

Tammy Fischer

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Acronym: ALD Biobank

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2020
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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