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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
Information provided by:

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:

  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.

Study Design

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
Primary Completion Date : January 2009
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

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, Senior)
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

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

Copenhagen S, Denmark, 2300
Sponsors and Collaborators
Statens Serum Institut
Bispebjerg Hospital
Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond
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

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

Keywords provided by Statens Serum Institut:
Serological reactions
Polymerase chain reaction

Additional relevant MeSH terms:
Rickettsia Infections
Lymphoproliferative Disorders
Lymphatic Diseases
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections