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Recruiting NCT04664192

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

Observational Respiratory Failure Interstitial Lung Disease Lung Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Biospecimen Registry (observational and blood sampling).
Who it may be relevant to
Registry conditions: Respiratory Failure, Interstitial Lung Disease, Lung Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Patient Biospecimen Registry (observational and blood sampling)
    Clinical data collected at every blood sample collection visit.

Primary outcome measures

  • Diagnosis of patients with lung transplant [Time frame: 5 years]
Secondary outcome measures (1)
  • Survival [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Baylor Scott & White Research Institute — Dallas

Identifiers

NCT: NCT04664192 · 021-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗