Trials Sponsors Conditions Drugs Pricing

Conditions

Lung Transplant; Complications Lung Transplant Failure Lung Transplant; Infection or Inflammation Lung Transplant Rejection

Outcome Measures

Primary Outcomes (3)

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
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
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

Study Arms (1)

Lung transplant donors and recipients

Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Lung transplant donors and adult (18 years and up) lung transplant candidates and recipients

You may qualify if:

Able to understand and provide informed consent

Sponsors & Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
NIHcollaborator
Duke University
Otherlead
University of Pennsylvania

Study Sites (19)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Jennifer PerezCONTACT000-000-0000 jsperez@mednet.ucla.edu

Shahrzad LariCONTACTshahrzadlari@mednet.ucla.edu

John BelperioPRINCIPAL INVESTIGATOR

University of California at San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The DCC will establish the centralized biorepository for the PROMISE-Lung Study at the University of Pennsylvania (Penn). Each specimen will be labeled with the study, sample ID, time-point, specimen type, and a unique barcode ID. Following local site processing, specimens will be locally stored at -80ᵒC at the participating site. Samples will then be batched and shipped on dry ice overnight to Penn at regular intervals. Shipments will be tracked to ensure arrival in a timely manner. Once received at Penn, all biological specimens for the cohort will be scanned into the laboratory information management system (LIMs) and stored at -80ᵒC. Biospecimens sent to Penn will be stored for future research studies.

MeSH Terms

Conditions

InfectionsInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Scott M Palmer, MD, MHS
Duke University School of Medicine, Department of Medicine
PRINCIPAL INVESTIGATOR
Jason D Christie, MD, MSCE
University of Pennsylvania
PRINCIPAL INVESTIGATOR
Megan L Neely, PhD
Duke University School of Medicine, Department of Biostatistics and Bioinformatics
PRINCIPAL INVESTIGATOR

Central Study Contacts

Allyn Damman

CONTACT

919-259-4414 allyn.damman@duke.edu

Carl Schuler, RN

CONTACT

919-695-2721

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 1, 2024

First Posted

May 3, 2024

Study Start

September 3, 2024

Actual (reported)

Primary Completion

June 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Lung transplant donors and recipients

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (19)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Lung transplant donors and recipients

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (19)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations