- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558597
Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation
July 19, 2011 updated by: Hannover Medical School
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jens Gottlieb, Dr. med.
- Phone Number: 3560 +49-511-5320
- Email: gottlieb.jens@mh-hannover.de
Study Contact Backup
- Name: Isabelle Bodmann
- Phone Number: 2667 +49-511-5320
- Email: bodmann.isabelle@mh-hannover.de
Study Locations
-
-
-
Hannover, Germany, 30625
- Recruiting
- Hannover Medical School
-
Contact:
- Jens Gottlieb, Dr. med.
- Phone Number: 3560 +49-511-5320
- Email: gottlieb.jens@mh-hannover.de
-
Sub-Investigator:
- Markus Berkefeld, Dr. med.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients after lung transplantation
Description
Inclusion Criteria:
- Patients with stable graft function
- Patients with acute rejection
Exclusion Criteria:
- Acute infection
- BOS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
30 patients with stable graft function
|
2
30 patients with acute rejection after lung transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jens Gottlieb, Dr. med., Hannover Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
November 14, 2007
First Submitted That Met QC Criteria
November 14, 2007
First Posted (Estimate)
November 15, 2007
Study Record Updates
Last Update Posted (Estimate)
July 21, 2011
Last Update Submitted That Met QC Criteria
July 19, 2011
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 154
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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