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NCT01985412 · ClinicalTrials.gov registry record

Genome Transplant Dynamics: Non-invasive Sequencing-based Diagnosis of Rejection

A clinical trial, sponsored by Stanford University.

Completed
Registry status
65
Enrollment target

NCT01985412: Completed study, sponsored by Stanford University.

NCT01985412 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 65 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01985412 has completed, sponsored by Stanford University.

COMPLETED
Registry status
65 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether shotgun sequencing technology, which can be used to detect donor DNA in recipient plasma, can be used as a rapid, accurate, non-invasive method to detect Acute Cellular Rejection (ACR) after heart transplantation. Currently, all heart transplant recipients undergo invasive heart biopsies to diagnose ACR. Thus, there is an ongoing need to monitor patients for the development of acute and chronic rejection, with the primary goal of non-invasive early detection and treatment to prevent organ damage.

Primary Outcome

We will use high throughput next generation sequencing to monitor the proportion of cell-free donor DNA to recipient DNA in the recipient's blood stream as a marker of rejection.

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2010-03
Est. Completion 2013-09-29
Stanford University

1,744 total trials

What the finished NCT01985412 record still lists

NCT01985412 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 65 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01985412 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01985412 about?

NCT01985412 is a clinical study titled "Genome Transplant Dynamics: Non-invasive Sequencing-based Diagnosis of Rejection". The purpose of this study is to determine whether shotgun sequencing technology, which can be used to detect donor DNA in recipient plasma, can be used as a rapid, accurate, non-invasive method to detect Acute Cellular Rejection (ACR) after heart transplantation. Currently, all heart transplant reci...

What is the current status of trial NCT01985412?

This trial is currently completed. The enrollment target is 65 participants. The study started on 2010-03. Estimated completion is 2013-09-29.

Who is sponsoring clinical trial NCT01985412?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01985412, the US trial registry maintained by the National Library of Medicine. NCT01985412 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.