Biomarker in Lung Diseases | NCT00989846

Studies
Biomarker in Lung Diseases

NCT00989846

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Oct 14, 2009Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Lung Diseases

Interventions

biomarker

Countries

Germany

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

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Oct 5, 2009

First Submission Date that Met QC Criteria

Oct 5, 2009

First Posted Date

Oct 6, 2009Estimated

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

Oct 13, 2009

Last Update Posted Date

Oct 14, 2009Estimated

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

Disease related biomarkers have been established decades ago, e.g. blood glucose for diabetes diagnosis and management. Their discovery has grown dramatically during the past decade and they have the potential to lead the physician in diagnosis -especially differential diagnosis - and therapy.

However, a specific serum-biomarker in lung diseases has not been established. Aim of the current study is to to measure lung specific proteins in the serum in patients with various lung diseases and to correlate those with disease severity, lung function and other laboratory results

Detailed Description

Not provided

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lung disease		patients with various chronic or acute lung diseases	Other: biomarker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biomarker	Other	measuring serum-biomarkers	lung disease

Measure	Description	Time Frame
Serum biomarker expression		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >= 18
acute or chronic lung disease

Exclusion Criteria:

HIV
lactation or gestation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with acute or chronic lung diseases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Kreuter, MD	Contact	49 / 6221 / 396	1201	michael.kreuter@thoraxklinik-heidelberg.de

Overall Officials

Name	Affiliation	Role
Michael Kreuter, MD	Thoraxklinik Heidelberg, Germany	Principal Investigator
Felix JF Herth, MD	Thoraxklinik Heidelberg Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care	Recruiting	Heidelberg		69126	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15972108	Background	Tzouvelekis A, Pneumatikos I, Bouros D. Serum biomarkers in acute respiratory distress syndrome an ailing prognosticator. Respir Res. 2005 Jun 22;6(1):62. doi: 10.1186/1465-9921-6-62.
16042760	Background	Tzouvelekis A, Kouliatsis G, Anevlavis S, Bouros D. Serum biomarkers in interstitial lung diseases. Respir Res. 2005 Jul 21;6(1):78. doi: 10.1186/1465-9921-6-78.