Liquid biopsiEs fOr luNg AllogRaft Damage classificatiOn - LEONARDO

NCT06679257 | Recruiting

• 1 other identifier: LEONARDO
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 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. .

Conditions

Lung Transplant Failure and Rejection; Lung Transplant Infection

Outcome Measures

Primary Outcomes (1)

• Damage distinction

  Null hypothesis: Levels of Cf-DNA is not different at samples taken with allograft damage and no allograft damage.

  One month, three months, one year, three years, five years

Secondary Outcomes (1)

• Damage detection Limit

  One month, three months, one year, three years, five years

Study Arms (1)

Lung transplanted patients

All eligible patients were transplanted and followed up within the catchment area of the participating centre.

Diagnostic Test: cell-free dNA

Interventions

cell-free dNA DIAGNOSTIC_TEST

Blood samples taker per protocol, analyses performed by a lab blinded to the status of the respective patients

Lung transplanted patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly lung transplanted patients within scandinavia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jesper Magnusson: lead

Study Sites (1)

Sahlgrenska University hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cell free DNA

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Noninvasive Prenatal Testing

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Liquid Biopsy; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Testing; Specimen Handling; Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Jesper M Magnusson, MD, PhD

CONTACT

+0463421000; jesper.magnusson@gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Associate professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 7, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)