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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Transplant Patients | Adult subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent. | ||
| 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. | ||
| Pregnant Transplant Patients | Pregnant subjects who have undergone at least one organ transplant prior to enrollment and are willing to provide consent. |
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| Measure | Description | Time Frame |
|---|---|---|
| To develop an assay to detect allograft rejection status in transplant patients involving amplification of donor-derived cell-free DNA from donor recipient blood. | The primary outcome of the assay developed in this study would be allograft rejection high risk or low risk. This assay result will be compared to the biopsy pathology report which assesses if the transplant organ is in a state of rejection, or not. We are also measuring the donor cell free DNA, which is presumably indicating of an organ being rejected or not. Alterations in the cut off of that donor derived cell free DNA level that is allocated to high risk of rejection will be explored. Sensitivity and specificity of our assay will be calculated as needed for the purpose of validating and improving our technology in detecting donor derived cfDNA from a transplant recipient's blood. No results will be reported to patients or their treating physicians. | 1-3 years |
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Inclusion Criteria:
Exclusion Criteria:
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As in Inclusion and Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Natera Inc. | San Carlos | California | 94070 | United States | ||
| Balboa United California Institute of Renal Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30583588 | Background | Sigdel TK, Archila FA, Constantin T, Prins SA, Liberto J, Damm I, Towfighi P, Navarro S, Kirkizlar E, Demko ZP, Ryan A, Sigurjonsson S, Sarwal RD, Hseish SC, Chan-On C, Zimmermann B, Billings PR, Moshkevich S, Sarwal MM. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2018 Dec 23;8(1):19. doi: 10.3390/jcm8010019. |
| Label | URL |
|---|---|
| Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR | View source |
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12.4.1 All laboratory specimens, evaluation forms, reports, and other records will be handled in a manner designed to maintain research participant confidentiality. All records will be kept in a secure storage area with limited access. Clinical information will not be released without the written permission of the research participant's guardian except as necessary for monitoring and auditing by the Sponsor, its designee, regulatory bodies, or the IRB, or the DSMB.
12.4.2 The Principal Investigator or Sub-Investigator and all employees and coworkers involved with this study may not disclose or use for any purpose other than performance of the study, any data, record, or other unpublished, confidential information disclosed to those individuals for the purpose of the study. Prior written agreement from the Sponsor or its designee must be obtained for the disclosure of any said confidential information to other parties
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Each participant will provide between 1 to 4 tubes of whole blood (dependent on age) and optional urine collection.
| San Diego |
| California |
| 92123 |
| United States |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| The Ohio State University | Columbus | Ohio | 43221 | United States |