Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399302
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-05-01
Brief Title:
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes PROMISE-Lung Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief Summary:
This project aims to collect detailed clinical data blood samples and patient-reported outcomes from 2600 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
Detailed Description:
This is an observational prospective multicenter cohort study of 2600 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24HL163122 | NIH | None | None |
| PROMISE Study | OTHER | LTC-DCC | httpsreporternihgovquickSearchU24HL163122 |