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Eliminating the Need for Pancreas Biopsy Using Peripheral Blood Cell-free DNA

NCT04166149 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-11-27

No results posted yet for this study

Summary

Donor-derived cell-free DNA (dd-cfDNA) has shown promise as an early marker for cellular injury caused by rejection. dd-cfDNA changes may also indicate other injuries that lead to progressive decline in transplant organ function associated with, in the case of kidney transplantation, the presence of interstitial fibrosis (IF) and tubular atrophy (TA) seen in biopsy specimens. Here, we will study the utility of dd-cfDNA to predict rejection in pancreas and pancreas-kidney recipients.

Conditions

  • Transplant;Failure,Kidney
  • Transplant; Failure, Pancreas
  • Rejection Acute Renal
  • Rejection Acute Pancreas

Interventions

DIAGNOSTIC_TEST

dd-cfDNA Blood Test

The cfDNA measurement isolated from the peripheral blood contains small amounts from the graft. The blood sample is collected in Cell-Free DNA BCT (blood collection) tubes. These are measured by their difference in SNP (single nucleotide polymorphisms) genotype to determine the ratio of donor to recipient through shotgun sequencing. Higher levels of dd-cfDNA in a patient experiencing rejection is measured as a higher percentage of the total cf-DNA.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER

  • Georgetown University

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2024-07-30
Completion
2024-09-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04166149 on ClinicalTrials.gov