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Next Generation Sequencing to Detect Acute Rejection in Lung Transplant Patients.

NCT05260372 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2022-03-02

No results posted yet for this study

Summary

Lung transplantation is a consolidated treatment in selected patients with end-stage respiratory diseases; however, acute rejection remains an important cause of lung allograft loss and a risk factor for chronic allograft dysfunction. Histopathological examination of lung tissue is the gold standard for the diagnosis of acute rejection, therefore recipients undergo surveillance transbronchial biopsy and bronchoalveolar lavage after transplantation. However, the obtained tissue is sometimes inadequate for histopathology, and the endoscopic procedure can lead to complications (bleeding, pneumothorax). The quantification of donor-derived cell-free DNA (ddcfDNA) in the recipient plasma has shown to be increased in case of acute rejection, and could represent an early and non-invasive diagnostic marker to detect acute rejection. We planned to enroll all patients aged 18 to 65 years old enlisted for lung transplantation at our centre. Patients undergoing retransplantation and patients with a history of prior solid organ transplantation were excluded. The quantification of donor-derived cell-free DNA was performed 15 days and 3, 6, and 12 months after transplantation, concurrently with the routine surveillance bronchoscopies as per our protocol; the same analysis was also conducted in case of suspected clinical rejection.

Conditions

  • Lung Transplant Rejection

Interventions

DIAGNOSTIC_TEST

Quantification of donor-derived cell-free DNA

Quantification of ddcfDNA on serial plasma samples during follow-up after lung transplantation

Sponsors & Collaborators

  • University of Milan

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Mario Nosotti, MD, Professor · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2022-11-30
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05260372 on ClinicalTrials.gov