Rickettsial Genesis to Sarcoidosis in Denmark

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ClinicalTrials.gov Identifier: NCT00326534

Recruitment Status : Completed

First Posted : May 17, 2006

Last Update Posted : March 9, 2009

Sponsor:

Collaborators:

Bispebjerg Hospital

Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond

Information provided by:

Statens Serum Institut

Study Description

Brief Summary:

One study has suggested a connection between an infection with Rickettsia species and sarcoidosis finding molecular evidence of rickettsial deoxyribonucleic acid (DNA) in two patients. Another study found no antibodies in twenty Swedish patients with sarcoidosis.

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.

Condition or disease
Sarcoidosis Rickettsia Infections

Detailed Description:

The study has three approaches to the subject:

A serological survey of rickettsial immunoglobin G (IgG)-antibodies in 50 patients with sarcoidosis compared to 50 blood donors without sarcoidosis.
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.
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.

Study Design

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Study Type :	Observational
Actual Enrollment :	36 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Rickettsial Genesis to Sarcoidosis in Denmark
Study Start Date :	September 2006
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Controls Patients without sarcoidosis, but requiring a fiberoptic bronchoscopy
Sarcoidosis patients Patients with newly diagnosed sarcoidosis

Outcome Measures

Biospecimen Retention: Samples With DNA

Buffy coats, serum, bronchoalveolar lavage fluid and transbronchial biopsies

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients referred to fiberoptic bronchoscopy in the department either because of sarcoidosis, hemoptysis, chronic cough, or cancer suspicion

Criteria

Inclusion Criteria:

Referred to fiberoptic bronchoscopy in the department either because of sarcoidosis, hemoptysis, chronic cough, or cancer suspicion

Exclusion Criteria:

Pregnant patients
Patients under the age of 18
Patients without consent
Patients with a registered wish of not having their samples used for research

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326534

Locations

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Denmark
Denmark
Copenhagen S, Denmark, 2300

Sponsors and Collaborators

Statens Serum Institut

Bispebjerg Hospital

Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond

Investigators

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Principal Investigator:	Claus B Svendsen, MD	Statens Serum Institut
Study Chair:	Nils Milman, MD	Rigshospitalet, Denmark
Study Chair:	Karen A Krogfelt, PhD	Statens Serum Institut

More Information

Publications of Results:

Svendsen CB, Milman N, Høier-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 Publications:

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.

Nilsson K, Påhlson 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. Epub 2002 Mar 21.

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Responsible Party:	Claus Bo Svendsen, MD, Statens Serum Institut
ClinicalTrials.gov Identifier:	NCT00326534
Other Study ID Numbers:	KF 01 303797 2006-41-6575
First Posted:	May 17, 2006 Key Record Dates
Last Update Posted:	March 9, 2009
Last Verified:	March 2009

Keywords provided by Statens Serum Institut:


Sarcoidosis Rickettsia Serological reactions Polymerase chain reaction

Additional relevant MeSH terms:

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Rickettsia Infections Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases	Rickettsiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections

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