600 Participants Needed

Diagnostic Tools for Lung Transplant

Recruiting at 16 trial locations
KS
RP
Overseen ByRobert Polakowski, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the relationship between certain blood markers, such as dd-cfDNA levels and HLA antibodies, and lung transplant health. Researchers are also evaluating the Molecular Microscope® Diagnostic System to assess its effectiveness in identifying issues in lung transplant biopsies. The trial seeks adults who have received a lung transplant and do not have cancer or multiple organ transplants. Those who have had a lung transplant and wish to contribute to future treatment improvements may find this trial suitable.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in lung transplant care.

Why are researchers excited about this trial?

Researchers are excited about the Trifecta-Lung cfDNA-MMDx method because it offers a non-invasive way to monitor lung transplant health using cell-free DNA (cfDNA). Unlike traditional biopsies, which require surgical procedures to obtain tissue samples, this technique analyzes DNA fragments from the bloodstream to detect signs of organ rejection or other complications. This approach not only reduces the risk and discomfort associated with invasive procedures but also provides real-time insights into transplant health, potentially leading to earlier interventions and improved patient outcomes.

Who Is on the Research Team?

PF

Philip F Halloran, MD PhD

Principal Investigator

Alberta Transplant Applied Genomics Centre, University of Alberta

Are You a Good Fit for This Trial?

Inclusion Criteria

Adult, Older adult

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Calibration

Calibration of the Prospera® test for T cell-mediated rejection and lung injury using dd-cfDNA levels against MMDx measurements

18 months
Multiple visits for biopsy and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after calibration and testing

6 months

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

One Lambda

Collaborator

Trials
3
Recruited
1,200+

Natera, Inc.

Industry Sponsor

Trials
56
Recruited
50,700+