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

NCT07243964 | Recruiting

• 1 other identifier: L25-802
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of ALAD

  through study completion, an average of 1 year

Interventions

longitudinal changes in multi-omics profiling of peripheral blood OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recipients undergoing single or double lung transplantation

You may qualify if:

• 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;
• No planned participation in other interventional trials during the study period that may impact immune function or pulmonary function;
• Retransplant patients will be considered as a new transplant event and may be included in the analysis.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chang Chen: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Chang Chen, MD,PHD

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junqi Wu

CONTACT

+8615618977421; wujunqi@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)