NCT00558597

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 21, 2011

Status Verified

September 1, 2008

First QC Date

November 14, 2007

Last Update Submit

July 19, 2011

Conditions

RejectionLung Transplantation

Keywords

ProteomicsLung Transplantation

Study Arms (2)

1

30 patients with stable graft function

2

30 patients with acute rejection after lung transplantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients after lung transplantation

You may qualify if:

  • Patients with stable graft function
  • Patients with acute rejection

You may not qualify if:

  • Acute infection
  • BOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

BAL (broncho alveolar lavage) urine

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Jens Gottlieb, Dr. med.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Gottlieb, Dr. med.

CONTACT

+49-511-5320gottlieb.jens@mh-hannover.de

Isabelle Bodmann

CONTACT

+49-511-5320bodmann.isabelle@mh-hannover.de

Study Design

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

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 15, 2007

Study Start

March 1, 2008

Study Completion

December 1, 2011

Last Updated

July 21, 2011

Record last verified: 2008-09

Locations

DE(1)