Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes

Lung Transplant; Complications Clinical Trial

— PROMISE  

Official title:

Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes: PROMISE-Lung Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06399302
• Other study ID #: Pro00114566
• Secondary ID: U24HL163122PROMI
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Minal Trivedi
• Phone: 919-757-7503
• Email: minal.trivedi[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2600
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to understand and provide informed consent

2. = 18 years of age at the time of written informed consent

3. Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days

• Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion/exclusion criteria.

Exclusion Criteria:

1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol

2. Pregnancy or plans to become pregnant

3. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Related Conditions & MeSH terms

• Inflammation
• Lung Transplant Failure
• Lung Transplant Rejection
• Lung Transplant; Complications

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI), University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Primary	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.	3 years
Primary	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.	3 years