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Recruiting NCT07243964

NCT07243964 Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation

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Clinical Trial Summary
NCT ID NCT07243964
Status Recruiting
Phase
Sponsor Chang Chen
Condition Lung Diseases
Study Type OBSERVATIONAL
Enrollment 244 participants
Start Date 2025-11-01
Primary Completion 2029-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
longitudinal changes in multi-omics profiling of peripheral blood

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 244 participants in total. It began in 2025-11-01 with a primary completion date of 2029-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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).

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 .

Contact & Investigator

Central Contact

Junqi Wu

✉ wujunqi@tongji.edu.cn

📞 +8615618977421

Principal Investigator

Chang Chen, MD,PHD

PRINCIPAL INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Frequently Asked Questions

Who can join the NCT07243964 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07243964 currently recruiting?

Yes, NCT07243964 is actively recruiting participants. Contact the research team at wujunqi@tongji.edu.cn for enrollment information.

Where is the NCT07243964 trial being conducted?

This trial is being conducted at Shanghai, China.

Who is sponsoring the NCT07243964 clinical trial?

NCT07243964 is sponsored by Chang Chen. The principal investigator is Chang Chen, MD,PHD at Shanghai Pulmonary Hospital, Shanghai, China. The trial plans to enroll 244 participants.

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