Recruiting

cfDNA-MMDx

Sponsor:

University of Alberta

Code:

NCT05837663

Conditions

Lung Transplantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05837663

Start date

Nov 1, 2023

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adult, Older adult

Exclusion Criteria:

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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Calibration of Prospera® test for T cell mediated rejection [ Time Frame: 18 months ]
  • Calibration of Prospera® test for antibody-mediated rejection [ Time Frame: 18 months ]
  • Calibration of Prospera® test for lung injury [ Time Frame: 18 months ]
  • Report calibrated Prospera® test results for rejection [ Time Frame: 6 months ]
  • Report calibrated Prospera® test results for lung injury [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Konrad S Famulski, PhD DSc

1 780 782 9463konrad@ualberta.ca

Locations

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

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Principal Investigator:

Rajat Walia, MD

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

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Duncan Lewis, BS, CCRP

Duncan.Lewis@medicine.ufl.edu

Principal Investigator:

Amir Emtiazjoo, MD, MSc

Mayo Clinic Florida, 4500 San Pablo Rd

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Stacey N Caster

Caster.Stacey@mayo.edu

Principal Investigator:

Remzi Bag, MD

Indiana University Methodist Hospital 1812 N. Capitol Ave Suite W131L

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Erin Sartoris, RN

esartoris@iuhealth.org

Principal Investigator:

Nikki Smith, MD

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

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Cheryl Pai

cpai3@jhu.edu

Principal Investigator:

Jeffrey Thiboutot, MD MHS

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

Recruiting

New York, New York, United States, 10032

Contacts

Shreena Patel, MPH, LPN

sp3646@cumc.columbia.edu

Principal Investigator:

Kemarut Laothmatas, MD

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

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Justin Rosenheck, DO

BAYLOR SCOTT & WHITE RESEARCH INSTITUTE , 3409 Worth Street

Recruiting

Dallas, Texas, United States, 75246

Contacts

Principal Investigator:

Samir Kumar, MD MBA

UT Southwestern Medical Center, 5939 Harry Hines Blvd.

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Irina L Timofte, MD

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

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Howard J Huang, MD

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

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Renee Walruff, BS

walruff@uthscsa.edu

Principal Investigator:

Lara Jones, DO

Department of Medicine, University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

Contacts

Principal Investigator:

Kieran Halloran, MD MSc

Alberta Transplant Applied Genomics Centre, University of Alberta

Recruiting

Edmonton, Alberta, Canada, T^g 2E1

Contacts

Konrad S Famulski, PhD DSc

1 7807829463konrad@ualberta.ca

Robert Polakowski, PhD

1 7804925091polakows@ualberta.ca

Principal Investigator:

Philip F Halloran, MD PhD

University Health Network, Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Principal Investigator:

Shaf Keshavjee, MD MSc

More Information

Sponsor

University of Alberta

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-07-17.