NCT00326534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 9, 2009

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

May 15, 2006

Last Update Submit

March 6, 2009

Conditions

Keywords

SarcoidosisRickettsiaSerological reactionsPolymerase chain reaction

Study Arms (2)

Controls

Patients without sarcoidosis, but requiring a fiberoptic bronchoscopy

Sarcoidosis patients

Patients with newly diagnosed sarcoidosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to fiberoptic bronchoscopy in the department either because of sarcoidosis, hemoptysis, chronic cough, or cancer suspicion

You may qualify if:

  • Referred to fiberoptic bronchoscopy in the department either because of sarcoidosis, hemoptysis, chronic cough, or cancer suspicion

You may not qualify if:

  • Pregnant patients
  • Patients under the age of 18
  • Patients without consent
  • Patients with a registered wish of not having their samples used for research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denmark

Copenhagen S, 2300, Denmark

Location

Related Publications (3)

  • Planck A, Eklund A, Grunewald J, Vene S. No serological evidence of Rickettsia helvetica infection in Scandinavian sarcoidosis patients. Eur Respir J. 2004 Nov;24(5):811-3. doi: 10.1183/09031936.04.00014604.

    PMID: 15516677BACKGROUND
  • Nilsson K, Pahlson C, Lukinius A, Eriksson L, Nilsson L, Lindquist O. Presence of Rickettsia helvetica in granulomatous tissue from patients with sarcoidosis. J Infect Dis. 2002 Apr 15;185(8):1128-38. doi: 10.1086/339962. Epub 2002 Mar 21.

    PMID: 11930323BACKGROUND
  • Svendsen CB, Milman N, Hoier-Madsen M, Dziegiel MH, Krogfelt KA. Determination of rickettsial and antinuclear antibodies in Danish patients with sarcoidosis. Clin Respir J. 2008 Oct;2(4):202-7. doi: 10.1111/j.1752-699X.2008.00051.x.

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coats, serum, bronchoalveolar lavage fluid and transbronchial biopsies

MeSH Terms

Conditions

SarcoidosisRickettsia Infections

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesRickettsiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsVector Borne Diseases

Study Officials

  • Claus B Svendsen, MD

    Statens Serum Institut

    PRINCIPAL INVESTIGATOR
  • Nils Milman, MD

    Rigshospitalet, Denmark

    STUDY CHAIR
  • Karen A Krogfelt, PhD

    Statens Serum Institut

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

September 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

March 9, 2009

Record last verified: 2009-03

Locations