Clinical Trials in Organ Transplantation Extension Study

NCT04126746 | Completed

• 2 other identifiers: Pro00102592PALMER19AB0
• Study Type: observational
• Target: 501
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of the study is to continue to follow subjects who were enrolled in the CTOT-20 CLAD Phenotypes study. Subjects will provide clinical data and complete quality of life questionnaires that will be used to determine the clinical factors associated with the development of Chronic Lung Allograft Dysfunction (CLAD) after lung transplant.

Conditions

Lung Transplant Failure and Rejection

Keywords

Lung transplantation; Chronic lung allograft dysfunction

Outcome Measures

Primary Outcomes (4)

• Time from lung transplant to Chronic Lung Allograft Dysfunction (CLAD) (including RCLAD or BOS) as measured by serial pulmonary function tests

  Time from lung transplant to the development of CLAD (Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS) as measured by a change in pulmonary function and Physician Adjudication

  Baseline, up to 24 months

• Number of participants that develop CLAD as measured by change in pulmonary function and Physician Adjudication

  Up to 24 months

• Number of participants that have Th1, Th2, Th17 immune profiles as measured in the lung fluid

  Up to 24 months

• Number of participants that have Th1, Th2, and Th17 immune profiles as measured in the blood

  Up to 24 months

Secondary Outcomes (4)

• Change in Quality of Life (QOL) as serially assessed by the Short Form 36 (SF-36)

  Baseline and annually for 2 years

• Change in Quality of Life (QOL) as serially assessed by the Saint George's Respiratory Questionnaire

  Baseline and annually for 2 years

• Time from CLAD onset to death as measured by medical record review

  Up to 24 months

• Time from CLAD onset to retransplant as measured by medical record review

  Up to 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include participants previously enrolled in the CTOT-20 study who are alive and remain active in the study (i.e. not previously withdrawn). The CTOT-20 cohort consists of adults who received their first lung transplant at one of the five participating centers (Duke University Medical Center, University of California Los Angeles Medical Center, Cleveland Clinic Foundation, Johns Hopkins University, Toronto General Hospital). Multi-organ recipients as well as prior recipients of any solid organ or bone marrow transplant were excluded. Recipients with HIV infection were excluded as were those participating in an investigational drug trial at the time of enrollment. At the time of this protocol writing, there are 625 out of 803 CTOT-20 participants alive and active in follow-up, who are eligible to participate.

You may qualify if:

• Current CTOT-20 participants

You may not qualify if:

• Non-CTOT-20 participants
• Withdrawn CTOT-20 participants

Sponsors & Collaborators

• Duke University: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (5)

University of California Los Angeles Medical Center

Los Angeles, California, 90024, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoaveolar lavage fluid - lung fluid obtained during a bronchoscopy procedure Blood collection by needle stick; blood collection separated into its components of serum, plasma, RNA

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Scott M Palmer, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: December 17, 2019
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (1)