Trifecta-Lung cfDNA-MMDx Study

NCT05837663 | Recruiting

• 1 other identifier: Pro00048176
• Study Type: observational
• Target: 600
• Locations: 4 countries
• Sites: 17

Brief Summary

Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung transplants.

Conditions

Lung Transplantation

Keywords

Donor derived cfDNA; Gene expression; Lung transplant biopsy; Blood

Outcome Measures

Primary Outcomes (5)

• Calibration of Prospera® test for T cell mediated rejection

  Set dd-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy (TBB and 3BMB) as reported by MMDx. Calibration of dd-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.

  18 months

• Calibration of Prospera® test for antibody-mediated rejection

  Set dd-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy (TBB and 3BMB) as reported by MMDx.

  18 months

• Calibration of Prospera® test for lung injury

  Set dd-cfDNA test cut-off values against the probability of acute and chronic lung injury in the biopsy (TBB and 3BMB)as reported by MMDx.

  18 months

• Report calibrated Prospera® test results for rejection

  Report new dd-cfDNA test cut-off values for rejection

  6 months

• Report calibrated Prospera® test results for lung injury

  Report new DD-cfDNA test cut-off values for lung injury

  6 months

Secondary Outcomes (4)

• Assessment of donor-specific antibody status

  6 months

• .Estimate the false positive rate of dd-cfDNA for MMDx and histology in indication and protocol biopsies

  6 months

• Determine whether calibrated dd-cfDNA blood test will replace biopsies

  6 months

• Determine whether calibrated dd-cfDNA blood test predicts the effect of treatment

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult lung transplant recipients undergoing indication biopsy for suspected graft dysfunction will be eligible.

You may qualify if:

• Adult, Older adult

You may not qualify if:

• Patients will be excluded from the study if they decline participation Are unable to give informed consent. Recipients of multiple organs, cancer patients and pregnant women

Sponsors & Collaborators

• University of Alberta: lead
• Natera, Inc.: collaborator
• One Lambda: collaborator

Study Sites (18)

St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT

Phoenix, Arizona, 85013, United States

RECRUITING

Division of Pulmonary, Critical Care and Sleep Medicine, University of Florida, College of Medicine

Gainesville, Florida, 32610, United States

RECRUITING

USF Health, Morsani College of Medicine, 12901 Bruce B. Downs Blvd. MDC40

Tampa, Florida, 33612, United States

RECRUITING

Indiana University Methodist Hospital 1812 N. Capitol Ave Suite W131L

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins Interventional Pulmonology, Sheikh Zayed Tower, Room 7125L, 1800 Orleans Street

Baltimore, Maryland, 21287, United States

RECRUITING

Division of Pulmonary, Allergy & Critical Care Medicine Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

The Ohio State University Wexner Medical Center, 410 W 10th Ave

Columbus, Ohio, 43210, United States

RECRUITING

BAYLOR SCOTT & WHITE RESEARCH INSTITUTE , 3409 Worth Street

Dallas, Texas, 75246, United States

RECRUITING

UT Southwestern Medical Center, 5939 Harry Hines Blvd.

Dallas, Texas, 75390, United States

RECRUITING

Houston Methodist Lung Transplant Center, 6550 Fannin St., SM1001

Houston, Texas, 77030, United States

RECRUITING

UT Health San Antonio 7703 Floyd Curl Drive, MSC: 7858

San Antonio, Texas, 78229, United States

RECRUITING

The Alfred Hospital, Monash University

Melbourne, Australia

RECRUITING

Department of Thoracic Surgery, Medical University of Vienna

Vienna, Austria

NOT YET RECRUITING

Department of Medicine, University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

RECRUITING

Alberta Transplant Applied Genomics Centre, University of Alberta

Edmonton, Alberta, T^g 2E1, Canada

RECRUITING

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Motol University Hospital, V Uvalu 84

Prague, 15006, Czechia

RECRUITING

Charles University/Hospital Motol

Prague, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

RNA isolated from patient biopsy cfDNA isolated from patient blood

Study Officials

• Philip F Halloran, MD PhD

  Alberta Transplant Applied Genomics Centre, University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad S Famulski, PhD DSc

CONTACT

1 780 782 9463; konrad@ualberta.ca

Robert Polakowski, PhD

CONTACT

1 780 492 5091; polakows@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 1, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); CA (3); CZ (2); US (11)