RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-05
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06399302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to understand and provide informed consent
  2. 2. ≥ 18 years of age at the time of written informed consent
  3. 3. Anticipated listing or listed for a single or bilateral cadaveric donor lung transplant or having received a lung transplant within 30 days
  4. * Participants undergoing repeat lung transplantation or multi-organ transplantation are eligible if they meet the inclusion/exclusion criteria.
  1. 1. Unwillingness of a participant or legally authorized representative (LAR) to give written informed consent or comply with study protocol
  2. 2. Pregnancy or plans to become pregnant
  3. 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.

Contacts and Locations

Study Contact

Allyn Damman
CONTACT
919-259-4414
allyn.damman@duke.edu
Carl Schuler, RN
CONTACT
919-695-2721
carl.schuler@duke.edu

Principal Investigator

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

Study Locations (Sites)

University of California at San Francisco
San Francisco, California, 94143
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-05
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-09-05
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

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