RejectionNCT00558597
Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation
An observational study of Rejection and Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rejection, Lung Transplantation
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients after lung transplantation
Who may be able to join
- Patients with stable graft function
- Patients with acute rejection
Who cannot join
- Acute infection
- BOS
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, 30625
Jens Gottlieb, Dr. med., +49-511-5320 ext. 3560, gottlieb.jens@mh-hannover.de
Markus Berkefeld, Dr. med.
About this study
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.
Read the 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.
- Conditions
- Rejection, Lung Transplantation
- Keywords
- Proteomics, Lung Transplantation
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 30 patients with stable graft function | |
| 2 | 30 patients with acute rejection after lung transplantation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startMar 2008
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Jens Gottlieb, Dr. med., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558597
- Sponsor's protocol ID
- 154
- Status last verified
- Sep 2008
- First submitted
- 14 Nov 2007
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation
- ClinicalTrials.gov ID
- NCT00558597
- Acronym / sponsor ID
- 154
- Conditions
- Rejection, Lung Transplantation
- Keywords
- Proteomics, Lung Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Mar 2008
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –30 patients with stable graft function |
| 2 | – | –30 patients with acute rejection after lung transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients after lung transplantation
Key inclusion criteria (2 listed)
- Patients with stable graft function
- Patients with acute rejection
Key exclusion criteria (2 listed)
- Acute infection
- BOS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Gottlieb, Dr. med. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rejection and Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Gottlieb, Dr. med. (+49-511-5320 ext. 3560, gottlieb.jens@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.