NCT07243964

Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation

Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation: A Prospective, Multicenter Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 244 (estimated)
• Sponsor: Chang Chen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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).

Detailed description

ALAD predominantly occurs in the early post-transplant period. This project aims to establish a systematic framework for monitoring and predicting post-lung transplant dysfunction, with a specific focus on acute lung allograft dysfunction (ALAD) and its progression to chronic lung allograft dysfunction (CLAD). We plan to conduct a prospective, multicenter clinical cohort study, longitudinally collecting peripheral blood and bronchoalveolar lavage fluid (BALF) samples from transplant recipients at various time points. By integrating multi-omics technologies-including cfDNA fragmentomics, peripheral blood single-cell sequencing, and proteomic mass spectrometry-with pulmonary function (FEV1) and clinicopathological data, we seek to delineate the dynamic landscape of post-lung transplant dysfunction. Compared to previous studies that relied on single indicators or one-time measurements, this project is distinguished by several key features: Firstly, the use of cfDNA fragmentomic characteristics to infer tissue origin, enabling highly specific detection of graft injury without requiring donor genotype information. Secondly, the integration of single-cell transcriptomics to comprehensively analyze the dynamics of peripheral immune cell subsets, providing a basis for early immunological warning of dysfunction. Thirdly, the application of proteomics to reveal expression levels, post-translational modifications, and protein-protein interactions in plasma samples. Fourthly, the construction of a multi-dimensional integrated model incorporating blood, BALF, and pulmonary function data, with the goal of establishing a generalizable early warning system. Through this research, we aim not only to enhance the early identification and intervention of ALAD but also to lay the foundation for elucidating the molecular mechanisms underlying CLAD development and exploring potential therapeutic targets.

Conditions

• Lung Diseases

Interventions

Type	Name	Description
OTHER	longitudinal changes in multi-omics profiling of peripheral blood	This 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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2029-12-31
• Completion: 2030-03-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: China