Health TrialsbyHealthPanel

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation

ConditionLung Transplant Rejection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who declined participation or unable to give informed consent.

Trial population

Patients with functioning lung transplant biopsied to determine their graft dysfunction or to confirm good function as per standard of care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lung transplant biopsy bites.

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.

Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.

Time frame
two years
2

Report the molecular diagnoses of the MMDx-TBB system

Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.

Time frame
two years

Secondary outcomes

1

Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies.

Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.

Time frame
two years
2

Report the molecular diagnoses of the MMDx-3BMB system

Compare MMDx-3BMB readings to MMDx-TBB readings and clinical diagnosis of CLAD

Time frame
two years
3

Report the molecular changes over time in medically indicated follow-up biopsies

Predict and monitor response to anti-rejection treatment.

Time frame
two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
Apply now