Clinical trial NCT00326534: Rickettsial Genesis to Sarcoidosis in Denmark
Official title: Rickettsial Genesis to Sarcoidosis in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Rickettsia Infections
Keywords: Sarcoidosis
Rickettsia
Serological reactions
Polymerase chain reaction
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond
First posted: 2006-05-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen S
country: Denmark
facility: Denmark
Study officials:
affiliation: Statens Serum Institut
name: Claus B Svendsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Nils Milman, MD
role: STUDY_CHAIR
affiliation: Statens Serum Institut
name: Karen A Krogfelt, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1183/09031936.04.00014604.
citation: 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.
citation: 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.