Rickettsial Genesis to Sarcoidosis in Denmark - Full Text View

Sponsors and Collaborators:	Statens Serum Institut Bispebjerg Hospital Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond
Information provided by:	Statens Serum Institut
ClinicalTrials.gov Identifier:	NCT00326534

Purpose

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
Sarcoidosis Rickettsia Infections

MedlinePlus related topics: Sarcoidosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Rickettsial Genesis to Sarcoidosis in Denmark

Further study details as provided by Statens Serum Institut:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Buffy coats, serum, bronchoalveolar lavage fluid and transbronchial biopsies

Estimated Enrollment:	250
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326534

Contacts

Contact: Claus B Svendsen, MD	+45 (32) 68 38 98	clv@ssi.dk
Contact: Karen A Krogfelt, PhD	+45 (32) 68 37 45	kak@ssi.dk

Locations

Denmark
Denmark	Recruiting
Copenhagen S, Denmark, 2300
Contact: Claus B Svendsen, MD +45 (32) 68 38 98 clv@ssi.dk
Contact: Klaus R Larsen, MD, PhD +45 (35) 31 35 31 richter@dadlnet.dk
Principal Investigator: Claus B Svendsen, MD

Sponsors and Collaborators

Statens Serum Institut

Bispebjerg Hospital

Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond

Investigators

Principal Investigator:	Claus B Svendsen, MD	Statens Serum Institut
Study Chair:	Nils Milman, MD	Rigshospitalet, Copenhagen, 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. The Clinical Respiratory Journal 2008; 2: 202-207.

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, 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. Epub 2002 Mar 21.

Responsible Party:	Statens Serum Institut ( Claus Bo Svendsen, MD )
Study ID Numbers:	KF 01 303797, 2006-41-6575
Study First Received:	May 15, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00326534
Health Authority:	Denmark: National Board of Health; Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Statens Serum Institut:

Sarcoidosis
Rickettsia
Serological reactions
Polymerase chain reaction

Study placed in the following topic categories:

Bacterial Infections
Lymphatic Diseases
Rickettsia Infections
Rickettsiosis

Sarcoidosis
Rickettsial disease
Lymphoproliferative Disorders
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Rickettsiaceae Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009