Multi-omics prediction of graft problems after lung transplant

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

We will test whether repeated blood and lung-fluid multi-omics tests can spot early graft dysfunction in adults after lung transplantation.

Quick facts

• Study type: Observational
• Enrollment: 244 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07243964 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter cohort that will collect blood and bronchoalveolar lavage fluid samples from lung transplant recipients over time. Researchers will apply cfDNA fragmentomics, peripheral blood single-cell RNA sequencing, and plasma proteomics and link these data to pulmonary function (FEV1) and clinical information. The goal is to build a multi-omics model to identify acute lung allograft dysfunction (ALAD) early and track progression toward chronic lung allograft dysfunction (CLAD). Longitudinal sampling and integration of multiple molecular layers distinguish this work from prior single-measurement or single-modality studies.

Who should consider this trial

Good fit: Adults (≥18) who have received single or double lung transplants, are clinically stable after surgery, can provide informed consent, and can attend scheduled follow-ups and sample collections.

Not a fit: Patients with active systemic infection or uncontrolled rejection, recent or untreated malignancy, pregnant or lactating women, those unable to comply with follow-up, or those enrolled in other immune‑impacting interventional trials may not receive benefit from participation.

Why it matters

Potential benefit: If successful, this approach could detect graft injury earlier and help guide interventions to reduce acute and chronic rejection and preserve lung function.

How similar studies have performed: Prior single-modality studies using donor-derived cfDNA, single-cell transcriptomics, or proteomics have shown promise for detecting graft injury, but integrated longitudinal multi-omics prediction in lung transplant recipients is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Recipients aged ≥18 years undergoing single or double lung transplantation;
2. 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;
3. Postoperative recipients clinically assessed as stable and eligible for routine follow-up and hematological examinations;
4. Recipients able to undergo dynamic pulmonary function monitoring during follow-up;
5. No planned participation in other interventional trials during the study period that may impact immune function or pulmonary function;
6. Retransplant patients will be considered as a new transplant event and may be included in the analysis.

Exclusion Criteria:

1. History of active malignancy or presence of untreated malignancy within 5 years prior to transplantation;
2. Presence of active systemic infection or significant immune rejection;
3. Female patients who are pregnant or lactating;
4. Any other condition deemed by the investigator to be inappropriate for inclusion .

Where this trial is running

Shanghai

• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Chang Chen, MD,PHD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: Junqi Wu

Conditions Lung Diseases