Rickettsial Genesis to Sarcoidosis in Denmark | NCT00326534

Studies
Rickettsial Genesis to Sarcoidosis in Denmark

NCT00326534

Sponsor

Statens Serum Institut

Status

Completed

Last Update Posted

Mar 9, 2009Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Sarcoidosis
Rickettsia Infections

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006-41-6575

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

May 15, 2006

First Submission Date that Met QC Criteria

May 15, 2006

First Posted Date

May 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2009

Last Update Posted Date

Mar 9, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Statens Serum InstitutOTHER

Collaborators

Name	Class
Bispebjerg Hospital	OTHER
Civilingeniør Johs. E. Ormstrup og Hustru Grete Ormstrups Fond	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

A serological survey of rickettsial immunoglobin G (IgG)-antibodies in 50 patients with sarcoidosis compared to 50 blood donors without sarcoidosis.
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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Controls		Patients without sarcoidosis, but requiring a fiberoptic bronchoscopy
Sarcoidosis patients		Patients with newly diagnosed sarcoidosis

Interventions

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denmark		Copenhagen S		2300	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15516677	Background	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.
11930323	Background	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.

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

ID	Term
D012507	Sarcoidosis
D012282	Rickettsia Infections