(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
A Study of the Natural Progression of Interstitial Lung Disease
Status: Recruiting
Location: University of Chicago
Conditions: University of Chicago
City/State:
Chicago, Illinois
Contact Information:
Spring Maleckar
773-834-4053
Brief Summary:
We propose to acquire data and blood samples on all patients being cared for by the Interstitial Lung Disease (ILD) program. Additionally, we will collect data and blood samples from a control group for comparator purposes. In doing so, we will be able to describe the “phenotypic” expression of these diseases.
Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension
Status: Recruiting
Location: University of Florida
Conditions: University of Florida
City/State:
Gainesville, Florida
Contact Information:
Christina M Eagan, DNP
352-273-8990
[email protected]
Name: Ali Ataya, RN
Phone Number: 352-273-8740
Email: [email protected]
Brief Summary:
This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
Detailed Description:
Pulmonary sarcoidosis-associated pulmonary hypertension is classified as WHO Group 5 pulmonary hypertension and may occur in anywhere from 5-20% of sarcoidosis patients. Inhaled treprostinil has shown clinical improvements in exercise capacity after 12 weeks of therapy in patients with WHO Group 1 pulmonary hypertension. More recently, there has been interest in using inhaled PAH-specific therapies for the treatment of pulmonary hypertension associated with interstitial lung disease.
The investigators believe that those patients with pulmonary hypertension in the setting of sarcoidosis-associated interstitial lung disease are a unique population which may potentially benefit from inhaled, targeted pulmonary arterial hypertension therapy (inhaled treprostinil) while minimizing the adverse effects associated with systemic pulmonary vasodilators. This study aims to evaluate the efficacy and safety of inhaled treprostinil in subjects with sarcoidosis-associated interstitial lung disease and pulmonary hypertension.
Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy
Status: Recruiting
Location: The George Washington University Hospital
Conditions: The George Washington University Hospital
City/State:
Washington D.C.
Contact Information:
Khalil Diab, MD
2027412180
[email protected]
Benjamin Delprete, DO
2027412180
[email protected]
Brief Summary:
The investigators will compare endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) with intranodal forceps biopsy (EBUS-IFB) as it relates to the rate of diagnosis of suspected sarcoidosis.
Detailed Description:
This is prospective, single center randomized comparative study to determine the diagnostic yield and specimen quality of endobronchial ultrasound guided intranodal forceps biopsy of patients with suspected sarcoidosis based solely on imaging. This will be a single group study and will compare transbronchial needle aspiration via 19 or 21-gauge needle with intranodal forceps biopsy.
The study aims to answer a knowledge gap a as to whether the diagnostic yield and specimen quality of EBUS-TBNA with a 19G needle is less than those obtained by 1.9mm or greater intranodal forceps biopsy. The study proposed here will add to the field by further elucidating whether this procedure is beneficial for the diagnosis as it pertains to suspected sarcoidosis.
The anticipated required enrollment is 55 patients to achieve an α of 0.05 and β of 0.2. This assumes an unassisted diagnostic yield of 62.5% with standard of care EBUS-TBNA as reported in Ray et al, and a diagnostic supplementation to 80% yield with intranodal forceps biopsies.
Full-Field Optical Coherence Tomography (FFOCT) for Evaluation of Bronchoscopic Small Biopsy Specimens
Status: Recruiting
Location: Johns Hopkins University
Conditions: Johns Hopkins University
City/State:
Baltimore, Maryland
Contact Information:
Jeffrey Thiboutot, MD
410-502-2533
[email protected]
Brief Summary:
This study sets out to register imaging of small biopsy specimens obtained during bronchoscopy using full-field optical coherence tomography against standard histologic evaluation.
Detailed Description:
Small biopsy specimens obtained through bronchoscopy are commonly employed for the diagnosis and staging of thoracic malignancies. Diagnostic yield is dependent on tissue quality and quantity in specimens obtained through bronchoscopy, and it is thus important to ensure adequate sampling. Rapid on-site cytology (ROSE) is a method used by having a cytotechnologist at the bedside to prepare and analyze specimens to improve the quality of tissue acquisition during bronchoscopy. Although effective, ROSE expertise is not always available to proceduralists, is costly, and reproducible techniques that can be deployed across multiple tiers of institutions are needed across the globe.
Optical coherence tomography (OCT) is an emerging technique which may provide real-time imaging with resolution approaching that of typical histopathology. This has several benefits over ROSE using histopathologic evaluation including rapid imaging with minimal tissue processing, preservation of tissue specimens for molecular testing, enhanced intracellular contrast, and adaptation to machine learning approaches to allow for a reproducible and consistent result. In fact, full-field OCT has recently been applied in several tissue types for evaluation of adequacy of pathologic specimens and evaluation of malignancy, among others. To the best of the investigators’ knowledge, this technology has not yet been evaluated for assessment of specimen quality in bronchoscopic procedures.
Thus, the investigators propose a study of full-field OCT for evaluation of small biopsy specimens obtained through bronchoscopy. The investigators aim to demonstrate the feasibility of this technology in the workflow of bronchoscopy and compare to current evaluation methods including rapid on-site evaluation (ROSE). ROSE is commonly used to evaluate adequacy of tissue diagnosis during bronchoscopic procedures including at this institution. However, studies have not shown definitive benefits over bronchoscopy without ROSE, and current expert guidelines suggest bronchoscopy with Endobronchial Ultrasound (EBUS) transbronchial needle aspiration (TBNA) may be performed with or without ROSE.
Full-field OCT has several potential benefits compared to ROSE, including rapid analysis with minimal tissue processing and preservation of tissue for further molecular testing. In addition, OCT has been used to assess surgical biopsy specimens in a non-destructive manner, so the tissues can be analyzed after imaging using standard cytological and pathological methods. Full-field OCT evaluation may be applied to other diseases in addition to further augmenting the diagnostic ability through the use of machine learning approaches.
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Medication Adherence in Patients With Sarcoidosis
Status: Recruiting
Location: Johns Hopkins Bayview Asthma and Allergy Center, Johns Hopkins Greenspring Station
Conditions: Johns Hopkins Bayview Asthma and Allergy Center, Johns Hopkins Greenspring Station
City/State:
Baltimore, Maryland
Timonium, Maryland
Contact Information:
Michelle Sharp, MD, MHS
410-550-7753
[email protected]
Amanda Sevilla, BA
410-550-1859
[email protected]
Brief Summary:
The goal of the study is to look at the relationship between how individuals with Sarcoidosis take the sarcoidosis medicines and how it affects the disease, to evaluate any factors that may make individuals not want to take the medicines, and to develop and refine ways to help support individuals with Sarcoidosis especially when it comes to the medicines. The overall hypothesis is higher medication adherence will be associated with better clinical outcomes in sarcoidosis. The investigators will enroll 150 patients with biopsy proven pulmonary sarcoidosis for at least one year who are on any oral treatment regimen for at least six months into a 12-month longitudinal study.
A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis
Status: Recruiting
Location: Xentria Investigative Site
Conditions: Xentria Investigative Site
City/State:
Greenville, North Carolina
Birmingham, Alabama
Denver, Colorado
Jacksonville, Florida
Chicago, Illinois
Iowa City, Iowa
Albany, New York
New York, New York
Philadelphia, Pennsylvania
Baltimore, Maryland
Minneapolis, Minnesota
Detroit, Michigan
Cincinatti, Ohio
Charleston, South Carolina
Houston, Texas
Charlottesville, Virginia
Contact Information:
Xentria, Inc.
224-443-4615
[email protected]
Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP)
Status: Recruiting
Location: University of Maryland, University of Texas Southwestern
Conditions: University of Maryland, University of Texas Southwestern
City/State:
Baltimore, Maryland
Dallas, Texas
Contact Information:
Laura Koth
4155144369
[email protected]
Jessica Cardenas
[email protected]
Brief Summary:
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.
Detailed Description:
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit.
Primary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis.
Secondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period.
The investigators will measure two types of blood markers to achieve this goal:
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- Clinically available blood markers that are available in most clinical labs
- Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs
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Use of CXCL9 as a Biomarker of Acthar Efficacy (Acthar)
Status: Recruiting
Location: University of California- San Francisco
Conditions: University of California- San Francisco
City/State:
San Fransisco, California
Contact Information:
Laura Koth, MD
(415) 514-4369
[email protected]
Brief Summary:
The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).
Detailed Description:
The investigators will test whether Acthar gel’s anti-inflammatory properties will modulate immune cells and lead to decreases in blood biomarkers and improvements in clinical parameters. Specific Aim 1 will examine the levels of the predictive biomarker, chemokine ligand 9 (CXCL9), and related transcripts, and determine whether they decrease in participants over time while taking Acthar. Specific Aim 2 will test whether the biologic changes measured in blood correlate to clinical markers, including lung function and symptom scores. Since the investigators have found that CXCL9 predicts clinical course, they hypothesize that CXCL9 transcript levels in the blood will decrease over time in pulmonary sarcoidosis participants whose clinical outcome measures improve with Acthar.
Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis
Status: Recruiting
Location: Duke University Medical Center
Conditions: Duke University Medical Center
City/State:
Durham, North Carolina
Contact Information:
Han W Kim, MD
919-668-3539
[email protected]
Raymond J. Kim, MD
919-668-3539
[email protected]
Brief Summary:
The primary objective of this study was to determine the ability of cardiac magnetic resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were to undergo CMR in addition to routine clinical evaluation.
Detailed Description:
In patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. Cardiovascular magnetic resonance (CMR) can detect cardiac involvement including minute amounts of myocardial damage. Therefore, the objective of this study was to determine the usefulness of CMR and compare it with standard clinical evaluation for cardiac involvement. Patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.
Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis
Status: Recruiting
Location: University of California- San Francisco
Conditions: University of California- San Francisco
City/State:
San Fransisco, California
Contact Information:
Victoria Wang, BS
415 476 9225
[email protected]
Brief Summary:
Sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by gene-environment interactions. Although sarcoidosis predominantly affects the lungs in most cases, the clinical disease course is highly variable and any organ can be affected leading to end organ damage despite currently available therapeutics that unfortunately also have numerous and potentially devastating side effects. The environmental triggers of sarcoidosis are unknown but several occupational, environmental and infectious agents have been associated with sarcoidosis in susceptible hosts. Exposure to these triggers result in inflammation, characterized by activation of CD4+ T-cells, cytokine production, subsequent recruitment of other immune cells, and granuloma formation. Although several genetic markers have been associated with sarcoidosis, none fully explain individual susceptibility or clinical course variability, strongly implicating the environment and epigenetics. We have the ability to generate a map of the epigenetic histone modifications in immune cells via Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and a map of transcriptome profiles via RNA-seq. The availability of histone and transcriptional signatures defining T cell activity in sarcoidosis will help identify the specific molecular programs affected by disease processes and can become the basis for future discovery of novel biomarker diagnostics in a clinical setting.