Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation

NCT ID: NCT04318587

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2023-12-30

Brief Summary

The use of Allosure to identify and quantify circulating donor-derived cell-free DNA to quantitate allograft injury in the early post-transplant period and determine its relationship to allograft failure.

Detailed Description

Single Center Prospective Cohort Study on De-Novo Lung Transplant recipients. AlloSure will be drawn as part of routine blood draws and sent to CareDx for analysis of dd-cfDNA. All data will be collected and stored in the hospital EMR, this will be examined with the AlloSure results to correlate outcomes.

Conditions

Lung Transplant Failure and Rejection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Allosure Arm

All subjects will be in arm one and will have AlloSure blood draws at multiple time points.

Group Type: EXPERIMENTAL

Allosure

Intervention Type: DIAGNOSTIC_TEST

Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Interventions

Allosure

Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Denovo lung transplant recipient
• Ability to understand written and spoken English

Exclusion Criteria

• Previous transplant or multi-organ transplant
• Unable to have blood draw for medical reason

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CareDx

INDUSTRY

Sponsor Role: collaborator

Pablo Sanchez

OTHER

Sponsor Role: lead

Responsible Party

Pablo Sanchez

Vice Chair, Benign Lung Diseases Surgical Director, Lung Transplant and ECMO, Director, Lung Transplant Research and ELVP Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pablo Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Program Director Residency Program

Locations

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY19090098

Identifier Type: -

Identifier Source: org_study_id