Prospective Multicenter Research on Donor & Recipient Management

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06399302
Study type	Observational
Source	Duke University
Contact	Minal Trivedi
Phone	919-757-7503
Email	minal.trivedi@duke.edu
Status	Not yet recruiting
Phase
Start date	June 1, 2024
Completion date	June 30, 2027

View Details

See also
Status	Clinical Trial	Phase
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Enrolling by invitation	`NCT05950724` - RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant	Early Phase 1
Active, not recruiting	`NCT05505422` - Routine Versus Selective Intraoperative ECMO in Lung Transplant	N/A
Recruiting	`NCT05081141` - HHV8 and Solid Organ Transplantation
Enrolling by invitation	`NCT04522388` - Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant	N/A
Completed	`NCT04165161` - Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography	N/A
Recruiting	`NCT05050955` - AlloSure Lung Assessment and Metagenomics Outcomes Study
Withdrawn	`NCT03258801` - Pirfenidone as Bridging Therapy for Lung Transplant in Patients Suffering From Idiopathic Pulmonary Fibrosis
Completed	`NCT04892719` - 4DX Functional Lung Imaging in the Diagnosis of Chronic Lung Allograft Dysfunction After Lung Transplantation	N/A
Completed	`NCT03221764` - Intraoperative Amiodarone to Prevent Atrial Fibrillation in Lung Transplant Patients	Phase 2
Active, not recruiting	`NCT04975607` - Live Music Therapy to Reduce Anxiety, Pain and Improve Sleep in Post-Operative Lung Transplant Patients: A Pilot Study	N/A
Completed	`NCT05116748` - COVID19 Vaccine in SOT Adult Recipients
Recruiting	`NCT03367221` - Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist	N/A
Recruiting	`NCT03276403` - Primary Graft Dysfunction Score in Lung Transplantation	N/A
Active, not recruiting	`NCT03656926` - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)	Phase 3
Completed	`NCT05242289` - Cytokine Adsorption in Lung Transplantation	N/A
Recruiting	`NCT04837339` - Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation	N/A
Not yet recruiting	`NCT04377139` - Management of Cytomegalovirus (CMV) Infection in Lung Transplant Recipients (LTR)
Terminated	`NCT03562416` - Continuation of Nintedanib After Single Lung Transplantation in IPF Subjects	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms