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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664192
• Status: Recruiting
• Start date: June 4, 2021
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2023
• Source: Baylor Research Institute
• Contact: Susan Mathai, MD
• Phone: 214-820-6856
• Email: Susan.Mathai[@]bswhealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Baylor Scott & White Research Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of patients with lung transplant	ICD 10 code for underlying lung disease	5 years
Secondary	Survival	Date of death	5 years