Proteomics Analysis for Recognition of Acute Cellular Rej... | NCT00558597

Studies
Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation

NCT00558597

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Jul 21, 2011Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Rejection
Lung Transplantation

Interventions

Not provided

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

Sep 2008

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

Mar 2008

Primary Completion Date

Not provided

Completion Date

Dec 2011Estimated

First Submitted Date

Nov 14, 2007

First Submission Date that Met QC Criteria

Nov 14, 2007

First Posted Date

Nov 15, 2007Estimated

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

Jul 19, 2011

Last Update Posted Date

Jul 21, 2011Estimated

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

In patients with acute rejection after lung transplantation the peptide profile in broncho-alveolar lavage (BAL) and urine should be compared in order to identify a paradigm that allows an non-invasive rejection therapy.

Detailed Description

Goal of the study is the establishment of biomarkers for early diagnosis of acute rejection, followed by a late validation of the paradigm with prospectively collected samples, which will be examined blinded.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		30 patients with stable graft function
2		30 patients with acute rejection after lung transplantation

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with stable graft function
Patients with acute rejection

Exclusion Criteria:

Acute infection
BOS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients after lung transplantation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jens Gottlieb, Dr. med.	Contact	+49-511-5320	3560	gottlieb.jens@mh-hannover.de
Isabelle Bodmann	Contact	+49-511-5320	2667	bodmann.isabelle@mh-hannover.de

Overall Officials

Name	Affiliation	Role
Jens Gottlieb, Dr. med.	Hannover Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School	Recruiting	Hanover		30625	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012059	Rejection, Psychology

Ancestor Terms

ID	Term
D012919	Social Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided