Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-14

Study Completion Date

2024-08-23

Brief Summary

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This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

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Detailed Description

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This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

Subjects who have had an organ transplant, who present at the clinic for a standard of care visit or consent for an extra research blood samples to be taken by mobile phlebotomy, meet the study's eligibility criteria and are willing to participate in this research, will be consented and enrolled in this study.

Subjects will provide at least one blood sample at study enrollment and up to three optional follow-up blood samples at future visits. Relevant medical data will also be collected for each patient enrolled.

Urine samples may also be collected at the above described time-points.

Up to 500 subjects over the age of 2 worldwide who meet the study eligibility criteria are expected to be enrolled in this study. The study includes adult, pregnant, and pediatric subjects.

Conditions

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Transplant Rejection Allograft Rejection Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult Transplant Patients

Adult subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent.

No interventions assigned to this group

Pediatric Transplant Patients

Pediatric subjects between ages 2-17 who have undergone at least one organ transplant prior to enrollment and are willing to provide assent/LAR is willing to provide consent.

No interventions assigned to this group

Pregnant Transplant Patients

Pregnant subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject must be 2 years old or older at the time of enrollment
* Subject or Legally Authorized Representative is willing and able to sign the informed consent form (and assent form, if applicable), prior to participation in any study-related procedures.
* Subject has received at least one organ transplant prior to enrollment.