Rickettsial Genesis to Sarcoidosis in Denmark

March 6, 2009 updated by: Statens Serum Institut

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen S, Denmark, 2300
        • Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 17, 2006

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01 303797
  • 2006-41-6575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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