Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2006-09-30
2009-03-31
Brief Summary
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This study will further enhance the subject by three different approaches in Danish patients.
The purpose of this study is to find serological and molecular evidence of an infection with Rickettsia species in Danish patients with sarcoidosis.
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Detailed Description
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1. A serological survey of rickettsial immunoglobin G (IgG)-antibodies in 50 patients with sarcoidosis compared to 50 blood donors without sarcoidosis.
2. An archival study using pre-existing lymph node biopsies, where immunohistochemical analysis, fluorescent in situ hybridization, and polymerase chain reaction will be applied to samples from 50 patients with sarcoidosis and compared to 50 patients without sarcoidosis and 10 patients with tuberculosis.
3. A prospective study using bronchoscopically obtained samples from 20 patients with sarcoidosis, compared to 20 patients without sarcoidosis. The study applies the same techniques as the second study, but enhancing the information from the patients.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Controls
Patients without sarcoidosis, but requiring a fiberoptic bronchoscopy
No interventions assigned to this group
Sarcoidosis patients
Patients with newly diagnosed sarcoidosis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients under the age of 18
* Patients without consent
* Patients with a registered wish of not having their samples used for research
18 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond
UNKNOWN
Statens Serum Institut
OTHER
Responsible Party
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Statens Serum Institut
Principal Investigators
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Claus B Svendsen, MD
Role: PRINCIPAL_INVESTIGATOR
Statens Serum Institut
Nils Milman, MD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Karen A Krogfelt, PhD
Role: STUDY_CHAIR
Statens Serum Institut
Locations
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Denmark
Copenhagen S, , Denmark
Countries
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References
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Planck A, Eklund A, Grunewald J, Vene S. No serological evidence of Rickettsia helvetica infection in Scandinavian sarcoidosis patients. Eur Respir J. 2004 Nov;24(5):811-3. doi: 10.1183/09031936.04.00014604.
Nilsson K, Pahlson C, Lukinius A, Eriksson L, Nilsson L, Lindquist O. Presence of Rickettsia helvetica in granulomatous tissue from patients with sarcoidosis. J Infect Dis. 2002 Apr 15;185(8):1128-38. doi: 10.1086/339962. Epub 2002 Mar 21.
Svendsen CB, Milman N, Hoier-Madsen M, Dziegiel MH, Krogfelt KA. Determination of rickettsial and antinuclear antibodies in Danish patients with sarcoidosis. Clin Respir J. 2008 Oct;2(4):202-7. doi: 10.1111/j.1752-699X.2008.00051.x.
Other Identifiers
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2006-41-6575
Identifier Type: -
Identifier Source: secondary_id
KF 01 303797
Identifier Type: -
Identifier Source: org_study_id
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