Multi-omics prediction of graft problems after lung transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Pulmonary Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Chang Chen, MD,PHD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: Junqi Wu
• Email: wujunqi@tongji.edu.cn
• Phone: +8615618977421

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.