Lung Transplant Failure and RejectionNCT04318587

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

A study testing Allosure in people with Lung Transplant Failure and Rejection, run by Pablo Sanchez at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Transplant Failure and Rejection
What is being tested?: Allosure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 29 Jun 2020to 30 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Read the 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
Being tested: Allosure
Medical subject headings: Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AllosureDiagnostic 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.

Study groups in NCT04318587
Study group	Role	What they receive
Allosure Arm	Experimental	All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Receives: Diagnostic Test: Allosure

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen).
Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200
If someone requires ECMO, they are automatically a grade 3.
Measured: 24 hours post transplant
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen).
Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200
If someone requires ECMO, they are automatically a grade 3.
Measured: 48 hours post transplant
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen).
Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200
If someone requires ECMO, they are automatically a grade 3.
Measured: 72 hours post transplant
Number of Participants With Allograft Rejection 3 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Measured: 3 months post transplant
Number of Participants With Allograft Rejection 6 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Measured: 6 months post transplant
Number of Participants With Allograft Rejection 9 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Measured: 9 months post transplant
Number of Participants With Allograft Rejection 12 Months Post Transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Measured: 12 months post transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) Pre-Transplant
Measured: pre-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 24 hours post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 48 hours post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 72 hours post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 1 week post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) 2 Weeks Post Transplant
Measured: 2 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 3 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 4 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 5 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 6 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 7 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 8 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 9 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 10 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 11 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 12 weeks post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 4 months post transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 5 months post transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 6 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 7 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 8 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 9 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 10 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 11 months post-transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Measured: 12 months post-transplant

Secondary outcomes (1)

Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant
The number of participants that were diagnosed as having chronic lung allograft dysfunction (CLAD), needed re-transplanted or died before 1 year post transplant.
Measured: one year post transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 202030 Dec 2023

First posted24 Mar 2020
Study start29 Jun 2020
Primary completion31 Dec 2022
Study completion30 Dec 2023

Why it stopped: Due to COVID and staffing shortages we decided to end the study with 40 participants instead of 50.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung Transplant Failure and RejectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Model description: Correlate donor DNA in blood samples to episodes of Acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry From this correlation we hope to be able to develop a miniMally invasive test ( blood sample) that can predict or correlate acute and or chronic rejection
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04318587
Sponsor's protocol ID: STUDY19090098
Status last verified: Mar 2024
First submitted: 17 Mar 2020
Last updated: 25 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
RecruitingObservational study
Plasma and Radiologic Biomarkers of Response to ECP in Lung Transplant Recipients With CLAD
Lung Transplant Failure and Rejection, CLAD, Bronchiolitis Obliterans
Active, not recruitingObservational study
AlloSure Lung Assessment and Metagenomics Outcomes Study
Lung Transplant Infection, Lung Transplant; Complications
Enrolling by invitationObservational study
Long Term Follow up of the LTOG Cohort
Lung Transplant Failure and Rejection
RecruitingObservational study
Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO
Lung Transplant Failure and Rejection, Lung Transplant Infection

All Lung Transplant Failure and Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation
ClinicalTrials.gov ID: NCT04318587
Acronym / sponsor ID: STUDY19090098
Conditions: Lung Transplant Failure and Rejection
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to COVID and staffing shortages we decided to end the study with 40 participants instead of 50.
Enrolment: 40 participants (actual)
Lead sponsor: Pablo SanchezUniversity, hospital or other
Collaborators: CareDx
Study start: 29 Jun 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 30 Dec 2023 (actual)
First posted: 24 Mar 2020 (actual)
Results: Posted 25 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Correlate donor DNA in blood samples to episodes of Acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry From this correlation we hope to be able to develop a miniMally invasive test ( blood sample) that can predict or correlate acute and or chronic rejection

Arm	Type	Receives
Allosure Arm	Experimental	Diagnostic Test: AllosureAll subjects will be in arm one and will have AlloSure blood draws at multiple time points.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AllosureBlood 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.	Diagnostic test	Allosure Arm

Primary outcome

Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant
Time frame: 24 hours post transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200 If someone requires ECMO, they are automatically a grade 3.
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant
Time frame: 48 hours post transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200 If someone requires ECMO, they are automatically a grade 3.
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant
Time frame: 72 hours post transplant
Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200 If someone requires ECMO, they are automatically a grade 3.
Number of Participants With Allograft Rejection 3 Months Post Transplant
Time frame: 3 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Number of Participants With Allograft Rejection 6 Months Post Transplant
Time frame: 6 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Number of Participants With Allograft Rejection 9 Months Post Transplant
Time frame: 9 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Number of Participants With Allograft Rejection 12 Months Post Transplant
Time frame: 12 months post transplant
Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant
Time frame: pre-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) Pre-Transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant
Time frame: 24 hours post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant
Time frame: 48 hours post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant
Time frame: 72 hours post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant
Time frame: 1 week post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant
Time frame: 2 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) 2 Weeks Post Transplant
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant
Time frame: 3 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant
Time frame: 4 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant
Time frame: 5 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant
Time frame: 6 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant
Time frame: 7 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant
Time frame: 8 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant
Time frame: 9 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant
Time frame: 10 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant
Time frame: 11 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant
Time frame: 12 weeks post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant
Time frame: 4 months post transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant
Time frame: 5 months post transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant
Time frame: 6 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant
Time frame: 7 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant
Time frame: 8 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant
Time frame: 9 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant
Time frame: 10 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant
Time frame: 11 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.
Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant
Time frame: 12 months post-transplant
dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

1 secondary outcome

Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant
Time frame: one year post transplant

Results and safety

Results posted to the registry on 25 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allosure Arm	40	40

Primary outcome: Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant

Time frame: 24 hours post transplant. Count of participants. Unit: Participants

Measure	Allosure Arm n = 40
PGD 1	15
PGD 2	2
PGD 3	8

Primary outcome: Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant

Time frame: 48 hours post transplant. Count of participants. Unit: Participants

Measure	Allosure Arm n = 40
PGD 1	19
PGD 2	1
PGD 3	10

Primary outcome: Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant

Time frame: 72 hours post transplant. Count of participants. Unit: Participants

Measure	Allosure Arm n = 40
PGD 1	15
PGD 2	1
PGD 3	11

Primary outcome: Number of Participants With Allograft Rejection 3 Months Post Transplant

Time frame: 3 months post transplant. Count of participants. Unit: Participants

Measure	Allosure Arm n = 40
Value	6

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allosure Arm	0 of 40 (0%)	0 of 40 (0%)	3 of 40

Limitations and caveats (from the sponsor): Not every patient had blood collected at the specified time points. Blood was missed at time of bronchoscopy or patient cancelled their bronchoscopy. 515 blood samples drawn and shipped to CareDx. 2 samples lost after they arrived at CareDx. Of the 513 samples assessed, we were not able to get the %dd-cfDNA data for 36 samples. This was due to sample quality and assay quality metrics. Hemolysis was the main reason for incomplete data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pablo Sanchez, MD principal investigator

Associate Program Director Residency Program

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Allosure in people with Lung Transplant Failure and Rejection, run by Pablo Sanchez at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant (time frame: 24 hours post transplant). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04318587.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.