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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
Sponsor:
Collaborators:
Bispebjerg Hospital
Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond
Information provided by:
Statens Serum Institut

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.

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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
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

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



Biospecimen Retention:   Samples With DNA
Buffy coats, serum, bronchoalveolar lavage fluid and transbronchial biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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

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


Locations
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Denmark
Denmark
Copenhagen S, Denmark, 2300
Sponsors and Collaborators
Statens Serum Institut
Bispebjerg Hospital
Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond
Investigators
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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
Publications of Results:
Other Publications:
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Responsible Party: Claus Bo Svendsen, MD, Statens Serum Institut
ClinicalTrials.gov Identifier: NCT00326534    
Other Study ID Numbers: KF 01 303797
2006-41-6575
First Posted: May 17, 2006    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009
Keywords provided by Statens Serum Institut:
Sarcoidosis
Rickettsia
Serological reactions
Polymerase chain reaction
Additional relevant MeSH terms:
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Rickettsia Infections
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Rickettsiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections