Pathogen Specific Immunity in Patients With Sarcoidosis

NCT00217789 | Completed

• 3 other identifiers: 0120040230; M-230-2004; 287R21HL077462-02R21HL077462
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the lung cells of healthy volunteers and patients with stage II and III pulmonary sarcoidosis for pathogen specific memory immunity and gene expression patterns.

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Pathogen Specific Immunity in Sarcoidosis

  Toxicity, DEP-Induced Cytokines, Effect of DEP on Stimulant-Induced Cytokine Production, in vitro Effects of DEP on M.tb-induced Cytokine Production, time kinetics of In vitro effects of DEP on M.tb-induced cytokine production, effect of DEP Exposure on M.tb H37Ra-induced Lymphocyte Proliferation, whole blood killing experiments

  July 2004 - June 2008

Interventions

Bronchoalveolar Lavage and Venipuncture PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sarcoidosis patients and healthy subjects

You may qualify if:

• Clinical and radiographic signs and symptoms consistent with pulmonary sarcoidosis stage II or III and confirmed histopathology
• No prior corticosteroid or immune suppressive or immune modulating therapies
• No clinical and radiographic signs and symptoms of respiratory or other chronic or systemic illness

You may not qualify if:

• Unwilling or unable to provide informed consent
• Unwilling or unable to comply with all study requirements
• History of upper or lower respiratory tract infection within 1 month of study entry
• History of major occupational or microbial exposures known to be associated with granulomatous inflammatory responses
• Positive HIV-1 serology
• Severe psychiatric disease
• Cough-induced syncope
• History of massive hemoptysis or history of pneumothorax, tuberculosis, and immunosuppressive therapies
• Presence of any chronic medical condition requiring daily medication
• Gingivitis or other infectious processes in the oral cavity
• Positive skin test to purified protein derivative (tuberculin)
• Hemoglobin level less than 10g/dl
• Illicit drug use or history of cigarette smoking within 1 year prior to study entry

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

Bronchoalveolar Lavage; Phlebotomy

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Stephan Schwander, MD, PhD

  University of Medicine and Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

US (1)