Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rickettsial Genesis to Sarcoidosis in Denmark

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 15, 2006
First Posted Date May 17, 2006
Last Update Posted Date March 9, 2009
Study Start Date September 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rickettsial Genesis to Sarcoidosis in Denmark
Official Title Rickettsial Genesis to Sarcoidosis in Denmark
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Buffy coats, serum, bronchoalveolar lavage fluid and transbronchial biopsies
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
Condition
  • Sarcoidosis
  • Rickettsia Infections
Intervention Not Provided
Study Groups/Cohorts
  • Controls
    Patients without sarcoidosis, but requiring a fiberoptic bronchoscopy
  • Sarcoidosis patients
    Patients with newly diagnosed sarcoidosis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2009)
36
Original Enrollment
 (submitted: May 15, 2006)
250
Actual Study Completion Date March 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00326534
Other Study ID Numbers KF 01 303797
2006-41-6575
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Claus Bo Svendsen, MD, Statens Serum Institut
Study Sponsor Statens Serum Institut
Collaborators
  • 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
PRS Account Statens Serum Institut
Verification Date March 2009