Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217789
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2005-09-19
Brief Title:
Pathogen Specific Immunity in Patients With Sarcoidosis
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Pathogen Specific Immunity in Sarcoidosis
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 antigens 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 Mtuberculosis 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 andor 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 pathogensantigens for the development of sarcoidosis
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 antigens 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 Mtuberculosis 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 andor 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 pathogensantigens for the development of sarcoidosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21HL077462 | NIH | None | httpsreporternihgovquickSearchR21HL077462 |
| R21HL077462-02 | NIH | None | None |