An observational study in Lung Transplant; Complications, Lung Transplant; Infection or Inflammation and Lung Transplant Rejection, sponsored by Duke University. Recruiting at 19 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Duke University · Observational
This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions.
This is an observational, prospective, multicenter cohort study of 2,600 lung transplant donors and adult (18 years and older) lung transplant candidates and recipients that will collect longitudinal clinical data, and serial biological (blood) specimens and PROs to support a broad range of clinical and translational future research. Data and biospecimens will be rigorously collected and monitored to ensure high quality future studies that will address unmet needs and optimal management at each stage of the transplant journey from listing, to donor selection, to postoperative management. Subjects are recruited to the study either prior to undergoing lung transplant at the time of listing or within 30 days of having undergone a lung transplant at one of the enrolling centers.
The study design will generally follow the SOC practices at each center to minimize additional research related visits. Participants will follow the SOC transplant protocols at each site. Every attempt will be made by the site to collect study data and research specimens from participants at the time of SOC visits. Participation in this study will include scheduled data extraction or data transfers at specified time intervals, serial prospective blood collection (including plasma, serum), recipient DNA sample collection (with donor DNA sample collection optional), and PRO measures.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 2,600 is above the median of 300 across 685 observational studies indexed under Infections.
Browse Infections studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients
Number of participants enrolled and critical variable completeness
To collect detailed clinical data, blood samples (including DNA), and PROs in 2,600 lung transplant candidates, donors, and recipients across the participating LTC centers to create a robust resource that will support a broad range of additional future clinical and translational research objectives
Time frame: 3 years
Number of PROs collected per patient
To collect clinical data and PROs that will specifically support future research studies to determine how variation in donor, surgical, or medical management practices across the participating LTC centers are associated with specific differences in relevant clinical outcomes such as PGD, AR, AMR, ALAD, post-transplant infections, PROs including health-related quality of life, or one-year survival.
Time frame: 3 years
Number of specimens per participant collected
To collect clinical data and biosamples that will specifically support future research studies to identify serum biomarkers that are associated with or predict the development of PGD, AR, AMR, ALAD, or CLAD.
Time frame: 3 years
Plan to share: Yes — After the study is completed, information about the study, including study data, will be submitted to the NIH data repository. NHLBI's BioData Catalyst will be used for data, and BioLINCC will be used for biosample deposition after study completion.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data from each cycle of an examination or follow-up component are prepared by the DCC and sent to the NHLBI Program Officer for distribution no later than 3 years after the completion of each examination or follow-up cycle or 2 years after the baseline, follow-up, genetic, ancillary study, or other data set is finalized within the study for analysis for use in publication, whichever comes first.
Access criteria: The overall governance of the protocol is under the guidance of the NHLBI and the steering committee, composed of members of the DCC and UO1 site representatives. Future studies using these sample will be governed by an ancillary committee of the steering committee. In addition, further analysis using this data may occur via ancillary studies that are submitted separately for IRB review. https://biodatacatalyst.nhlbi.nih.gov/ https://biolincc.nhlbi.nih.gov/home/
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jun 2027, 33 months after the start.
Of 257 non-industry observational studies under Infections, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 33 months is close to that.
Counting every sponsor, half of 295 studies reached it within 35 months; a quarter within 18 and three quarters within 67.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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