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

Pablo Sanchez

Status: Terminated

Conditions: Lung Transplant Failure and Rejection

Treatments: Diagnostic Test: Allosure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04318587

STUDY19090098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Allosure Arm

Experimental group

Description:

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

Treatment:

Diagnostic Test: Allosure