About this trial
By establishing a prospective, multicenter lung transplantation clinical cohort, this study aims to systematically evaluate the utility of cfDNA fragmentomics, peripheral blood single-cell sequencing, and proteomics in monitoring and predicting graft dysfunction after lung transplantation, and to develop a multi-omics predictive model for early identification, dynamic monitoring, and mechanistic investigation of acute lung allograft dysfunction (ALAD) and chronic lung allograft dysfunction (CLAD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Recipients aged ≥18 years undergoing single or double lung transplantation;
Postoperative recipients capable of understanding and providing written informed consent, and willing to comply with scheduled follow-ups and sample collections as required by the study;
Postoperative recipients clinically assessed as stable and eligible for routine follow-up and hematological examinations;
Recipients able to undergo dynamic pulmonary function monitoring during follow-up;
Disqualifiers
History of active malignancy or presence of untreated malignancy within 5 years prior to transplantation;
Presence of active systemic infection or significant immune rejection;
Female patients who are pregnant or lactating;
Any other condition deemed by the investigator to be inappropriate for inclusion .
Trial population
Recipients undergoing single or double lung transplantation
Trial design
Cohort
Prospective
Treatments tested in this trial
longitudinal changes in multi-omics profiling of peripheral blood
Other interventionThis study investigates the associations between longitudinal changes in multi-omics profiling of peripheral blood-including cell-free DNA, single-cell transcriptomics, proteomics, and metabolomics-and the development of acute lung allograft dysfunction(ALAD) and chronic lung allograft dysfunction(CLAD) in lung transplant recipients at various postoperative time points.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of ALAD
Sponsors and contacts
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Chang Chen
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution