Liquid biopsies to classify lung graft damage (LEONARDO)
Liquid Biopsies for Lung Allograft Damage Classification
This study will test whether a blood-based PCR cell-free DNA test combined with other markers can quickly distinguish rejection, infection, and other types of lung transplant graft damage in people who have had a lung transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg, Västra Götaland County) |
| Trial ID | NCT06679257 on ClinicalTrials.gov |
What this trial studies
This is a single-centre prospective observational cohort of lung transplant recipients followed at Sahlgrenska University Hospital. Blood will be drawn at fixed follow-up visits and at clinical events, and an in-house PCR-based cell-free DNA (cfDNA) assay will be combined with specific additional biomarkers to identify the type of allograft damage. Every sampling will be paired with the current clinical gold-standard diagnostics, and all biomarker analyses will be performed blinded at a separate laboratory. Control samples will consist of time points without detected allograft damage.
Who should consider this trial
Good fit: Ideal candidates are people who have received a lung transplant and are followed at or can attend Sahlgrenska University Hospital and can read and sign consent in the provided languages.
Not a fit: People who are not lung transplant recipients, who are not followed at or cannot attend the participating centre, or who cannot read and sign consent in the provided languages are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the test could allow faster and more accurate detection of rejection or infection after lung transplant, enabling earlier targeted treatment and potentially improving long-term outcomes.
How similar studies have performed: Donor-derived cfDNA approaches have shown promise in other organ transplants and preliminary lung transplant work, but a direct-to-clinic PCR cfDNA method remains relatively new and is still being validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Luing Transplanted and followed up within the reach of the study paricipating centres. A good understanding to read and write within the languages in which the consent is provided. Exclusion Criteria: * Not Lung Transplanted or not followed up within the reach of the study paricipating centres. No good understanding to read and write within the languages in which the consent is provided.
Where this trial is running
Gothenburg, Västra Götaland County
- Sahlgrenska University hospital — Gothenburg, Västra Götaland County, Sweden (Recruiting)
Study contacts
- Study coordinator: Jesper M Magnusson, MD, PhD
- Email: jesper.magnusson@gu.se
- Phone: +0463421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.