Rickettsial Genesis to Sarcoidosis in Denmark

NCT ID: NCT00326534

Last Updated: 2009-03-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Sarcoidosis Rickettsia Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond

UNKNOWN

Sponsor Role collaborator

Statens Serum Institut

OTHER

Sponsor Role lead

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

Site Status

Countries

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Denmark

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.

Reference Type BACKGROUND
PMID: 15516677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11930323 (View on PubMed)

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.

Reference Type RESULT
PMID: 20298335 (View on PubMed)

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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