Basic Research

This data repository involves collecting names, a brief medical history, and some descriptive data from volunteers 12 years of age and older who have a history of lung disease and who have expressed interest in being a participant or legal guardian has expressed interest in their child being a participant in clinical research studies conducted by the Department of Pulmonary Medicine. Minor subjects who reach adulthood will either be contacted to provide consent as an adult or they will be removed from the database. This final data set will be used solely for Pulmonary Medicine recruitment purposes.

This data repository involves collecting names, a brief medical history, and some descriptive data from potential healthy volunteers who have expressed interest in being a participant in clinical research studies conducted by the Department of Pulmonary Medicine. This final data set will be used solely for Pulmonary Medicine recruitment purposes.

This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up, clinical outcome events and patient reported outcome data. Blood samples will be collected periodically throughout the study for use in future research efforts. For participants with non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected throughout the study for use in future research efforts.

The purpose of this registry study is to collect information on the long-term safety and effectiveness of the Spiration Valve System in a real-world setting. This study will look at safety by tracking adverse events (health problems that may or may not be related to the device) and survival.

Recent data suggests that patients with certain genetic variants may have a decreased immune response to their transplanted lungs and, therefore, may be protected from developing rejection.

We are, therefore, collecting genetic information (DNA) obtained from lung transplant recipients during routine transplant clinic visits.

We are also recording all transplant related medical events in our research database so we can look for patterns of complications after transplant. We will use the DNA to evaluate whether genetic differences increase or decrease one’s risk for rejection or other complications after lung transplant.

The BRPC protocol is a single protocol that allows DUHS patients to give broad consent to donation of biospecimens annotated and paired with their identifying information. The lung transplant research team has partnered with the BRPC for approximately 7 years to procure and bank and study explanted native lung tissue at the time of lung transplantation for a variety of native lung diseases, including idiopathic pulmonary fibrosis, cystic fibrosis, COPD, pulmonary hypertension, and CLAD/BOS. Additionally, blood specimens may be collected from subjects who consent to that option.

This donor repository aims to collect for future research samples from lung transplant donors.

The primary study objective is to create a Database and Specimens Repository to allow for the storage of biospecimens and clinical information through the recruitment of patients with COPD who are completing Pulmonary Rehabilitation and those who are not completing Pulmonary Rehabilitation. The Database and Specimens Repository will support future research studies investigating the impact of Pulmonary Rehabilitation on the cellular metabolism of patients with COPD.

The primary objective of this project is to develop a comprehensive and extensive repository of biological samples and relevant clinical data from critically ill patients admitted to an ICU setting with the intent to develop collaboration across Duke and other external institutions. Specifically, the repository intends to collect biological samples and clinical data from COVID-19 positive patients who have been admitted to Duke inpatient services.

At this time, the repository is being developed to support collaboration across Duke University and other external institutions to Duke with the intent to facilitate in their overall research projects related to critically ill patients discharged from Duke hospital with follow-up in Duke pulmonary clinics. Specifically, at the present time, we intend to allow collaborators (internal and external) to utilize the biorepository to ascertain relevant clinical data and crucial biological samples, such as, but not limited to, plasma and
serum (blood draw), oral/nasopharyngeal swabs, questionnaire data (SF-12, PHQ-9, CAT, CV Resp, modified BORG) and relevant clinical data (via electronic medical record) from COVID-19 positive patients who were admitted to Duke Hospital, Duke Regional Hospital or Duke Raleigh Hospital Inpatient settings.

The biological samples are collected at 6 weeks, 3 months, 6 months and 12 months post-discharge when patients are seen in pulmonary clinic.

This project seeks to discover novel biomarkers of lung injury and repair in blood and respiratory samples from patients that have recovered from COVID-19. Our hypothesis is that a set of proteins measured in blood can predict which patients will experience lung recovery and which will develop irrecoverable pulmonary fibrosis.

Our analytical approach will employ both hypothesis-driven protein measurements from blood of post-COVID19 clinic patients (Western blotting and ELISA) performed by the Lee lab, as well as discovery proteomics and metabolomics performed by the Duke Proteomics Core. For the ELISA studies, we will have free access to the multiplex plate reader located in the MSRB I (Personal Communication, Dr. Rob Tighe). Eligible subjects will be those individuals who meet criteria listed in the IRB approved application, Pro00105518. Standard data analysis will be performed with support from the Duke Biostatistics and Bioinformatics Core.

We have identified Toll-like Receptor-4 (TLR4) and Macrophage migration inhibitory factor (MIF) as protective molecules that determine susceptibility to COPD and hyperoxia. Autopsy samples from patients with COVID-19 infection are rare, and their collection presents a unique opportunity to discover novel biomarkers and potential therapeutic drug targets, as well as test levels of TLR4 and MIF.

As part of the COVID-19 Autopsy working group (Pro00035974), we will receive various tissue samples collected during autopsies. We will measure gene expression in tissue slices by hybridization using the NanoString spatial profiling platform at the Duke Pathology Core. We will simultaneously probe for SARSCoV- 2 viral RNA. For other slices we will localize innate immune, alveolar and endothelial biomarkers using immunofluorescence and immuno-eletron microscopy.

Our study team will obtain tissue samples [and data, if applicable] in a de-identified form from the Duke University BioRepository & Precision Pathology Center (BRPC) Pro00035974 shared resource. Excess tissue not needed for diagnostic purposes and additional tissue for research purposes will be collected with subject consent by the BRPC under the Excess Tissue Consent and Additional Biopsy Consent, respectively. Any tissue collected from autopsies will be collected by the BRPC under their decedent waiver. At no time will I, as PI, have access to patient identifying information. All samples [and data, if applicable] will be deidentified, with the BRPC retaining the link as honest brokers.