Lung Transplant Failure and RejectionLEONARDONCT06679257
Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO
An observational study of Lung Transplant Failure and Rejection and Lung Transplant Infection, run by Jesper Magnusson at 1 site in Sweden.
Trial summary
LTx has the shortest survival of all solid organ transplants. The complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this. The current study aims overarchingly to improve survival after lung transplantation (LTx) through precise and fast diagnostics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Failure and Rejection, Lung Transplant Infection
- What is being tested?
- cell-free dNA
- How many people
- 146 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2024to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly lung transplanted patients within scandinavia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University hospital
Gothenburg, Västra Götaland County, 413 45
Jesper M Magnusson, MD, PhD, +046313421000, jesper.magusson@gu.se
About this study
Official title: Liquid Biopsies for Lung Allograft Damage Classification
LTx has the shortest survival of all solid organ transplants. The complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this.
The current study aims overarchingly to improve survival after lung transplantation (LTx) through precise and fast diagnostics. The specific aim is to develop direct-to-clinical implementation biomarkers for the most important aspects of long-term survival after LTx. An in-house-developed PCR-based cell-free-DNA methodology (cf-DNA) will be used for allograft damage and combined with specific other biomarkers to identify damage type. The current clinical golden standard for damage identification will be performed at every sampling instance.
Read more
The research will be a single-centre prospective observational cohort study. The control samples at all time points will consist of the samples without allograft damage. Blood will be drawn at fixed time points and clinical events. All analyses will be performed at a separate lab, blinded to the patient's status.
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- Being tested
- cell-free dNA
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell-free dNADiagnostic test
Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients
| Study group | Role | What they receive |
|---|---|---|
| Lung transplanted patients | All eligible patients were transplanted and followed up within the catchment area of the participating centre. Receives: Diagnostic Test: cell-free dNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Damage distinction
Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage.
Measured: One month, three months, one year, three years, five years
Secondary outcomes (1)
Damage detection Limit
If the null hypothesis is disproven, measure optimal cut off for distincition beteween samples indicating damage and not indicating damage. Also distinction between different types of damage, finally if distinction is attainable trhough association wit other known biomarkers.
Measured: One month, three months, one year, three years, five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start15 Nov 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant Failure and RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesper Magnusson
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jesper Magnusson, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679257
- Sponsor's protocol ID
- LEONARDO
- Acronym
- LEONARDO
- Status last verified
- Sep 2025
- First submitted
- 28 Oct 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsies for Lung Allograft Damage Classification
- ClinicalTrials.gov ID
- NCT06679257
- Acronym / sponsor ID
- LEONARDO / LEONARDO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Jesper MagnussonOther government
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LTx has the shortest survival of all solid organ transplants. The complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this.
The current study aims overarchingly to improve survival after lung transplantation (LTx) through precise and fast diagnostics. The specific aim is to develop direct-to-clinical implementation biomarkers for the most important aspects of long-term survival after LTx. An in-house-developed PCR-based cell-free-DNA methodology (cf-DNA) will be used for allograft damage and combined with specific other biomarkers to identify damage type. The current clinical golden standard for damage identification will be performed at every sampling instance.
The research will be a single-centre prospective observational cohort study. The control samples at all time points will consist of the samples without allograft damage. Blood will be drawn at fixed time points and clinical events. All analyses will be performed at a separate lab, blinded to the patient's status.
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplanted patients | – | Diagnostic Test: cell-free dNAAll eligible patients were transplanted and followed up within the catchment area of the participating centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly lung transplanted patients within scandinavia
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cell-free dNABlood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients | Diagnostic test | Lung transplanted patients |
Primary outcome
Damage distinction
Time frame: One month, three months, one year, three years, five years
Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage.
1 secondary outcome
Damage detection Limit
Time frame: One month, three months, one year, three years, five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant Failure and Rejection and Lung Transplant Infection, run by Jesper Magnusson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesper M Magnusson, MD, PhD (+0463421000, jesper.magnusson@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Damage distinction (time frame: One month, three months, one year, three years, five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.