Rickettsial Genesis to Sarcoidosis in Denmark

Sarcoidosis Clinical Trial

Official title:

Rickettsial Genesis to Sarcoidosis in Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326534
• Other study ID #: KF 01 303797
• Secondary ID: 2006-41-6575
• Status: Completed
• Phase: N/A
• First received: May 15, 2006
• Last updated: March 6, 2009
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of HealthDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Description:

The study has three approaches to the subject:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rickettsia Infections
• Sarcoidosis

Locations

Country	Name	City	State
Denmark	Denmark	Copenhagen S

Sponsors (3)

Lead Sponsor	Collaborator
Statens Serum Institut	Bispebjerg Hospital, Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond

Country where clinical trial is conducted

Denmark, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation