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

NCT ID: NCT04664192

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-04
• Study Completion Date: 2026-12-01

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.

Conditions

Respiratory Failure; Interstitial Lung Disease; Lung Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Lung transplant Recipients

Biobank registry for Lung transplant recipients

Patient Biospecimen Registry (observational and blood sampling)

Intervention Type: OTHER

Clinical data collected at every blood sample collection visit.

Interventions

Patient Biospecimen Registry (observational and blood sampling)

Clinical data collected at every blood sample collection visit.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Susan Mathai

Pulmonary Disease specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Mathai, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott & White Research Institute

Locations

Baylor Scott & White Research Institute

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Susan Mathai, MD

Role: CONTACT

Susan.Mathai@bswhealth.org

214-820-6856

Lorie Estrada

Role: CONTACT

Lorie.Estrada@BSWHealth.org

Facility Contacts

Brianna Kamran

Role: primary

Brianna.Kamran@BSWHealth.org