SarcoidosisNCT00217789
Pathogen Specific Immunity in Patients With Sarcoidosis
An observational study of Sarcoidosis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Bronchoalveolar Lavage and Venipuncture
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sarcoidosis patients and healthy subjects
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, 07103
About this study
Official title: Pathogen Specific Immunity in Sarcoidosis
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.
Read the detailed description
BACKGROUND:
Since its initial description 125 years ago, sarcoidosis continues to be a "challenging" disease. Its etiology remains unknown. Discovering the etiology of sarcoidosis remains a major goal with important implications regarding treatment, predicting outcome, as well as determining approaches for preventive measures. Immunological responses and granulomatous tissue formation characterizing sarcoidosis are similar to those observed in a variety of infectious diseases. However, the nature of the specific antigen(s), which putatively trigger the inflammatory response in sarcoidosis, remains elusive. Occurrence of sarcoidosis in spatially related clusters, and household and health care settings strongly support person-to-person transmission of an infectious agent as one of the potential causes of this disease. Sarcoidosis has been associated with a variety of infectious agents, none of which can be cultured. Propionibacterium acnes (P. acnes) and M.tuberculosis (Mtb) are the most commonly identifiable infectious pathogens by PCR-based methods and considered to be associated with the development of this disease. Immunological studies in sarcoidosis have focused largely on the assessment of constitutive, immune responses and the description of the phenotypes of blood and lung cells in patients and control subjects.
DESIGN NARRATIVE:
This study will utilize memory immune responses as search tools for the 'immunological imprints' from P. acnes or Mtb exposure. Peripheral blood mononuclear cells and bronchoalveolar cells will be compared from patients with stage II and/or stage III sarcoidosis and from healthy control subjects. Investigators will use ELISPOT assay to study: (1) frequencies of pathogen-specific interferon-7 and interleukin-10-producing cells, and (2) utilizing P. acnes- or Mtb-infected autologous monocytes and alveolar macrophages as target cell frequencies of pathogen-specific granzyme B-releasing cytotoxic T lymphocytes and natural killer cells. Finally, investigators will test the feasibility of identifying by DNA micro array, pathogen specific, transcriptional host gene expression profiles in P. acnes- and Mtb-stimulated blood cells from healthy control subjects and patients with active sarcoidosis and to compare these with gene expression profiles from autologous, unstimulated in situ lung cells. The studies will address the role of P. acnes and Mtb in the etiology of sarcoidosis and will also serve as a basis or model for future work involving other possible infectious or non-infectious pathogens/antigens for the development of sarcoidosis.
- Conditions
- Sarcoidosis
- Being tested
- Bronchoalveolar Lavage and Venipuncture
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoalveolar Lavage and VenipunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: July 2004 - June 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Stephan Schwander, MD, PhD, Principal investigator, University of Medicine and Dentistry of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217789
- Sponsor's protocol ID
- 0120040230; M-230-2004; 287
- Other IDs
- R21HL077462-02, R21HL077462
- Status last verified
- Dec 2013
- First submitted
- 19 Sep 2005
- Last updated
- 24 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogen Specific Immunity in Sarcoidosis
- ClinicalTrials.gov ID
- NCT00217789
- Acronym / sponsor ID
- 0120040230; M-230-2004; 287
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
Since its initial description 125 years ago, sarcoidosis continues to be a "challenging" disease. Its etiology remains unknown. Discovering the etiology of sarcoidosis remains a major goal with important implications regarding treatment, predicting outcome, as well as determining approaches for preventive measures. Immunological responses and granulomatous tissue formation characterizing sarcoidosis are similar to those observed in a variety of infectious diseases. However, the nature of the specific antigen(s), which putatively trigger the inflammatory response in sarcoidosis, remains elusive. Occurrence of sarcoidosis in spatially related clusters, and household and health care settings strongly support person-to-person transmission of an infectious agent as one of the potential causes of this disease. Sarcoidosis has been associated with a variety of infectious agents, none of which can be cultured. Propionibacterium acnes (P. acnes) and M.tuberculosis (Mtb) are the most commonly identifiable infectious pathogens by PCR-based methods and considered to be associated with the development of this disease. Immunological studies in sarcoidosis have focused largely on the assessment of constitutive, immune responses and the description of the phenotypes of blood and lung cells in patients and control subjects.
DESIGN NARRATIVE:
This study will utilize memory immune responses as search tools for the 'immunological imprints' from P. acnes or Mtb exposure. Peripheral blood mononuclear cells and bronchoalveolar cells will be compared from patients with stage II and/or stage III sarcoidosis and from healthy control subjects. Investigators will use ELISPOT assay to study: (1) frequencies of pathogen-specific interferon-7 and interleukin-10-producing cells, and (2) utilizing P. acnes- or Mtb-infected autologous monocytes and alveolar macrophages as target cell frequencies of pathogen-specific granzyme B-releasing cytotoxic T lymphocytes and natural killer cells. Finally, investigators will test the feasibility of identifying by DNA micro array, pathogen specific, transcriptional host gene expression profiles in P. acnes- and Mtb-stimulated blood cells from healthy control subjects and patients with active sarcoidosis and to compare these with gene expression profiles from autologous, unstimulated in situ lung cells. The studies will address the role of P. acnes and Mtb in the etiology of sarcoidosis and will also serve as a basis or model for future work involving other possible infectious or non-infectious pathogens/antigens for the development of sarcoidosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sarcoidosis patients and healthy subjects
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoalveolar Lavage and Venipuncture | Procedure or surgery | – |
Primary outcome
Pathogen Specific Immunity in Sarcoidosis
Time frame: July 2004 - June 2008
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Schwander, MD, PhD principal investigator
University of Medicine and Dentistry of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogen Specific Immunity in Sarcoidosis (time frame: July 2004 - June 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.