Clinical trial NCT04664192: Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research
Official title: Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Failure
Interstitial Lung Disease
Lung Diseases
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung transplant recipients

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of patients with lung transplant
timeFrame: 5 years
Secondary outcomes:
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
Study officials:
affiliation: Baylor Scott & White Research Institute
name: Susan Mathai, MD
role: PRINCIPAL_INVESTIGATOR
References: