Clinical trial Recruiting at 1 site Observational Ages 18 and up

Liquid biopsies to classify lung graft damage (LEONARDO)

Official title: Liquid Biopsies for Lung Allograft Damage Classification

Run by Vastra Gotaland Region · NCT06679257 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexAll
Enrollment146 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Gothenburg, Västra Götaland County)
StatusRecruiting
StartedNovember 15, 2024
Main results expectedDecember 2029
Study endsDecember 2030
Registry record updatedSeptember 16, 2025
Trial IDNCT06679257 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Sahlgrenska University hospital
    Gothenburg, Västra Götaland County, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.