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NCT02109575 · ClinicalTrials.gov registry record
Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)
A clinical trial, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- 540
- Enrollment target
NCT02109575 is a clinical trial that has completed, run by Medical College of Wisconsin. The registered enrollment target is 540 participants.
The verdict
NCT02109575 has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- 540 participants
- Enrollment target
Study Summary
The primary goal of this Multicenter Study is to develop and to evaluate a method for measuring donor-specific cell free DNA in blood samples from transplant recipients as markers of rejection. Blood samples obtained periodically from heart transplant recipients are assessed for cell free DNA relative to clinical data in order to determine whether changes in the level of cell free DNA indicate rejection. This research study proposes testing a blood sample obtained from the heart transplant recipient. The research seeks to establish whether this blood test will show when the patient is beginning to or already rejecting the transplanted heart. BACKGROUND Identifying if a transplant patient is beginning to or already rejecting the heart is necessary, so that appropriate treatment can be started to halt the rejection. Heart catheterization with biopsy is the usual method used for assessing whether a patient may be rejecting the heart. There are also a number of other methods that transplant physicians will use to look for signs of rejection including other blood tests, echocardiograms, obtaining pressure readings during heart catheterization, and micro-array testing of blood obtained during biopsy. These technologies are limited in ability to consistently and accurately identify the presence of rejection. The usual method of checking for rejection involves obtaining a sample of the heart tissue (heart biopsy); biopsy can only be accomplished through heart catheterization which is an invasive procedure that has risks associated with disturbing the heart such as puncturing the heart or causing the heart rate to change or damaging tissue in the heart. Overtime, repeating this invasive procedure can diminish the ease of the procedure because the veins can become scarred and more difficult to access. For these reasons, researchers believe that it would be good to have a blood test that gives information about the possibility of rejection so that it may not be necessary to
Interventions
- DIAGNOSTIC_TEST Blood Draw of up to 10 ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2014-03-01 |
| Est. Completion | 2020-03-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02109575
The ClinicalTrials.gov registry entry for NCT02109575 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Blood Draw of up to 10 ml is the first listed.
NCT02109575 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02109575 about?
NCT02109575 is a clinical study titled "Quantitative Detection of Circulating Donor-Specific DNA in Organ Transplant Recipients (DTRT-Multi-Center Study)". The primary goal of this Multicenter Study is to develop and to evaluate a method for measuring donor-specific cell free DNA in blood samples from transplant recipients as markers of rejection. Blood samples obtained periodically from heart transplant recipients are assessed for cell free DNA relati...
What is the current status of trial NCT02109575?
This trial is currently completed. The enrollment target is 540 participants. The study started on 2014-03-01. Estimated completion is 2020-03-30.
What interventions are being tested in trial NCT02109575?
The interventions under investigation include: Blood Draw of up to 10 ml (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02109575?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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