Recruiting

Microarrays

Sponsor:

University of Alberta

Code:

NCT02812290

Conditions

Lung Transplant Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lung transplant biopsy bites.

Study Details

Brief summary:

Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.

Conditions

Lung Transplant Rejection

Study ID

NCT02812290

Start date

May, 2016

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.

Exclusion Criteria:

  • Patients who declined participation or unable to give informed consent.

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Interventions

Lung transplant biopsy bites.

In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability.

Primary outcome measure

  • Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies. [ Time Frame: two years ]
  • Report the molecular diagnoses of the MMDx-TBB system [ Time Frame: two years ]

Central Contacts and Locations

Central contacts

Konrad S Famulski, PhD

1 780 492 1725konrad@ualberta.ca

Robert Polakowski, PhD

1 780 492 5091polakows@ualberta.ca

Locations

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

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Chanti F Smith

214-820-1771chanti.smith@dignityhealth.org

Principal Investigator:

Rajat Walia, MD

Alberta Transplant Applied Genomics Centre, University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2E1

Contacts

Konrad S Famulski, PhD

1 780 492 1725konrad@ualberta.ca

Principal Investigator:

Philip F Halloran, MD, PhD

Department of Medicine, University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

Contacts

Kieran Halloran, MD

1 780 492 2691kieran.halloran@ualberta.ca

Principal Investigator:

Kieran Halloran, MD

More Information

Sponsor

University of Alberta

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • antibody mediated rejection
  • T cell mediated rejection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-28.