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Rickettsial Genesis to Sarcoidosis in Denmark

This study has been completed.
Sponsor:
Collaborators:
Bispebjerg Hospital
Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond
Information provided by:
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT00326534
First received: May 15, 2006
Last updated: March 6, 2009
Last verified: March 2009
History of Changes
  Purpose

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
Sarcoidosis
Rickettsia Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Rickettsial Genesis to Sarcoidosis in Denmark

Resource links provided by NLM:

MedlinePlus related topics: Sarcoidosis
U.S. FDA Resources

Further study details as provided by Statens Serum Institut:

Biospecimen Retention:   Samples With DNA

Buffy coats, serum, bronchoalveolar lavage fluid and transbronchial biopsies


Enrollment: 36
Study Start Date: September 2006
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
Patients without sarcoidosis, but requiring a fiberoptic bronchoscopy
Sarcoidosis patients
Patients with newly diagnosed 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326534

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

Publications:
Svendsen CB, Milman N, Høier-Madsen M, Dziegiel MH, Krogfelt KA. Determination of rickettsial and antinuclear antibodies in Danish patients with sarcoidosis. The Clinical Respiratory Journal 2008; 2: 202-207.

Responsible Party: Claus Bo Svendsen, MD, Statens Serum Institut
ClinicalTrials.gov Identifier: NCT00326534     History of Changes
Other Study ID Numbers: KF 01 303797, 2006-41-6575
Study First Received: May 15, 2006
Last Updated: March 6, 2009
Health Authority: Denmark: National Board of Health
Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on May 23, 2013