Lung DiseasesNCT07243964
Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation
An observational study of Lung Diseases, run by Chang Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- longitudinal changes in multi-omics profiling of peripheral blood
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Mar 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Recipients undergoing single or double lung transplantation
Who may be able to join
- 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.
Who cannot join
- 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;
- Any other condition deemed by the investigator to be inappropriate for inclusion .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Junqi Wu, +8615618977421, wujunqi@tongji.edu.cn
About this study
Official title: Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation: A Prospective, Multicenter Cohort Study
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).
Read the 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
- Being tested
- longitudinal changes in multi-omics profiling of peripheral blood
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
longitudinal changes in multi-omics profiling of peripheral bloodOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ALAD
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Nov 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Chang Chen, MD,PHD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243964
- Sponsor's protocol ID
- L25-802
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics-Based Prediction of Allograft Dysfunction After Lung Transplantation: A Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07243964
- Acronym / sponsor ID
- L25-802
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Chang ChenUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recipients undergoing single or double lung transplantation
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
- Any other condition deemed by the investigator to be inappropriate for inclusion .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| longitudinal changes in multi-omics profiling of peripheral bloodThis 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. | Other | – |
Primary outcome
Incidence of ALAD
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chang Chen, MD,PHD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Chang Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junqi Wu (+8615618977421, wujunqi@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ALAD (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025; AzTrials last refreshed its copy on 3 Nov 2026.