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Department of Internal Medicine
Division of Pulmonary, Critical Care, and Sleep Medicine






Research

The Division of Pulmonary, Critical Care and Sleep Medicine has an active translational research program with several NIH grants, as well as corporate and device trials. We provide extensive laboratory facilities with access to cutting-edge techniques. In addition, our animal facilities support ongoing studies involving animal models of human disease (asthma, PAP, sarcoidosis). Targeted research areas include:

  • Sarcoidosis and lung inflammation
  • Cytokine biology
  • All aspects of lung cancer and interventional pulmonology
  • Alveolar proteinosis and lung lipid homeostasis
  • Obstructive lung disease.
Research Studies and Clinical Trials

Studies in Lung Biology Collection of Material for Tissue Banking

UMCIRB #: 05-354
Supported by: Genentech, Incorporated
PI: Mary Jane Thomassen, PhD
Sub-Investigator(s): Isham Huizar, MD
Study Coordinator: Irene Marshall, PA-C, CCRC
Contact: (252) 744-5888 (phone), (252) 744-4887 (fax)
Email: ECU_SARCOID_REGISTRY@ecu.edu

At East Carolina University, there is a research effort to understand the biological circumstances that lead to lung disease. As a result, there are several studies being performed that involve different groups of investigators. This is due to the fact that lung diseases are associated with many biological factors which require a "team" approach for investigation. Since several studies involve the use of blood and lung cells obtained during bronchoscopy and residual tissue from lung surgery, we are establishing a "tissue bank" of these specimens. Subjects for these studies will be: 1) patients who come to our Pulmonary Outpatient Clinic for diagnosis and treatment of lung disease 2)patients who undergo surgery for lung disease, and 3) healthy volunteers (controls) who are recruited for this study through advertisement. The subjects may be cigarette smokers. Normal volunteers should be free of acute or chronic respiratory symptoms.

Cytokine Dysregulation in GM-CSF Autoimmunity

UMCIRB #: 05-354
Supported by: Genentech, Incorporated
PI: Mary Jane Thomassen, PhD
Sub-Investigator(s): Isham Huizar, MD
Study Coordinator: Irene Marshall, PA-C, CCRC
Contact: (252) 744-5888 (phone), (252) 744-4887 (fax)

The long-term objective of this study is to delineate the relationships among immune cells, cytokines and anti-GM-CSF autoantibody in PAP pathophysiology. This study will use banked blood samples and banked tissue from bronchoscopy and, therefore, allow the study of lung fluids and cells, as well as systemic cells and mediators from blood. This protocol will enroll 10 patients with PAP being treated with Rituximab under the protocol "Prospective Open-Label Trial for Primary Pulmonary Alveolar Proteinosis," 20 untreated healthy controls for a single bronchoscopy, and 70 untreated healthy controls for a single venous blood draw. The 10 PAP patients will be 18 years of age or older from throughout the United States who have been diagnosed with primary PAP (PAP that develops from unknown reasons).

PPARg Dysfunction in Sarcoidosis

UMCIRB #: 05-0631
Supported by: National Institues of Health
PI: Mary Jane Thomassen, PhD
Sub-Investigator(s): Isham Huizar, MD
Study Coordinator: Irene Marshall, PA-C, CCRC
Contact: (252) 744-5888 (phone), (252) 744-4887 (fax)

The specific aims of this study are to: (1) Evaluate intrinsic PPARg mRNA (by real time RT-PCR) and protein expression (by immunoblotting and immunocytochemistry) in pulmonary granuloma tissue and bronchoalveolar lavage (BAL) cells; (2) Investigate in vitro PPARg responses of BAL and peripheral blood cells to challenge with positive (interleukin 4 [IL-4], granulocyte-macrophage colony stimulating factor [GM-CSF]), phorbol myristate acetate [PMA]; and negative (PPARg ligands, IFNg) regulators of PPARg; and (3) Determine by sequence analysis whether PPARg polymorphisms are associated with sarcoidosis. The study will use a combination of specimens from sarcoidosis patients vs healthy controls to characterize the status of PPARg in sarcoidosis.

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis

ClinicalTrials.gov Identifier: NCT00955279
Protocol: 1275148SCD2001
Supported by: Centocor, Inc.
PI: Isham Huizar, MD
Sub-Investigator(s): Mary Jane Thomassen, PhD
Study Coordinator: Irene Marshall, PA-C, CCRC
Contact: (252) 744-5888 or (252) 744-6834 (phone), (252) 744-4887 (fax)
Email: ECU_SARCOID_REGISTRY@ecu.edu

This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with sarcoidosis. The study will be conducted at approximately 40 sites globally. Patients can remain on usual, accepted treatment for sarcoid while enrolled in the study. Patients receiving corticosteroids at the beginning of the study will be required to begin tapering at Week 16 of the study. Participating in other experimental studies or taking other experimental medications while participating in this study will not be allowed.

Site-Specific Sub-Study for Bronchoalveolar Lavage Samples

Protocol: 1275148SCD2001
Supported by: Centocor, Inc.
PI: Isham Huizar, MD
Sub-Investigator(s): Mary Jane Thomassen, PhD
Study Coordinator: Irene Marshall, PA-C, CCRC
Contact: (252) 744-5888 or (252) 744-6834 (phone), (252) 744-4887 (fax)
Email: ECU_SARCOID_REGISTRY@ecu.edu

In this sub-study, both the cellular and acellular components present in BAL fluid (BALF) taken from subjects with pulmonary sarcoidosis will be analyzed using a variety of methods including gene microarray technology and proteomic analyses to search for biomarker patterns or "signatures." Previously, gene expression analysis was performed on tissues obtained from patients with sarcoidosis at the time of diagnosis and compared with normal lung tissue (Crouser et al, 2009). In this study, markers that were potential mediators of lung damage, remodeling, and disease activity were identified. By examining the patterns of biomarkers from BAL samples, it may be possible to correlate these patterns with clinical disease and the response to treatment with golimumab and ustekinumab. Thus, BAL has the potential to be a less invasive means than the current gold standard of lung biopsy in the clinical management of sarcoidosis. In addition, the potential of correlating biomarkers in BAL samples with those in serum could lead to minimally invasive and more facile method of diagnosing and managing patients with sarcoidosis. A separate study in normal healthy subjects will also be conducted in which BAL and serum samples will be obtained for comparison with those in this study.

East Carolina University (ECU) Central Slide Reading
CENTOCOR Sarcoidosis Trial 1275148SCD2001

Protocol: 1275148SCD2001
Supported by: Centocor, Inc.
PI: Mary Jane Thomassen, PhD
Sub-Investigator(s): Isham Huizar, MD
Study Coordinator: Irene Marshall, PA-C, CCRC
Contact: (252) 744-5888 or (252) 744-6834 (phone), (252) 744-4887 (fax)
Email: ECU_SARCOID_REGISTRY@ecu.edu

Timely review of slide quality and provide feedback to the sites regarding cytospin technique.

Upon notification and receipt of blinded bronchoalveolar lavage (BAL) cytospin slides from study site, ECU will verify slides received, verify data sheet received, and check in slides for storage. The initial slides undergo a quick overview read within 2 business days in order to provide a quality report and general feedback to the study site in a timely manner. The brief overview read will consist of a 100-cell count looking at cell distributions between squamous cells, bronchial epithelial cells and white blood cells. ECU will report to the study site as to whether the BAL slide is of adequate quality based on several criterions.

Healthy Volunteers Needed for Clinical Study

If you are over 18 years of age with:

  • No history of lung disease
  • No history of flu, chest cold, or urinary tract infection for the past six (6) weeks
  • No current respiratory symptoms 

The study will take about four (4) hours and will involve a bronchoscopy study of the lung and/or blood draw.

For more information contact:

Irene Marshall, PA-C, Clinical Studies Coordinator
marshalli@ecu.edu or (252) 744-5888 or (252) 744-6834

or 

Mary Catherine Cashion, BSN, RN, Clinical Studies Coordinator
cashionm@ecu.edu or (252) 744-2652 or (252) 744-5524

or

MeShall Hills, Public Communications Specialist
hillsm@ecu.edu or (252)744-3451

Financial Compensation will be provided.

 

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