Clinical Trials in Organ Transplantation Extension Study (CTOT-ES)

Clinical Trials in Organ Transplantation Extension Study (CTOT-ES)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Transplant Failure and Rejection

Detailed Description

There are no mandated study visits, rather the study will be conducted using real world data collected as part of usual clinical care according to the standard of care transplant protocols at each site. Specimens and study data will be collected during standard of care visits and study coordinators will review medical records and extract available clinical data every 6 months. Study coordinators will collect Pulmonary Function Test data that will be transferred to the Data Coordinating Center as in CTOT-20. Subjects will be asked to complete quality of life questionnaires on an annual basis.

The majority of times, blood samples will be collected during clinical care routine venipuncture based on clinic visit scheduling. In the rare circumstances in which research blood is missed during a standard of care venipuncture or one is not scheduled, a participant may be asked to undergo venipuncture for study purposes.

Standard of care (SOC) bronchoscopies with collection of Bronchoalveolar Lavage (BAL) lung fluid will be performed at each center according to clinical management protocols. During SOC bronchoscopies, research participants will undergo additional fluid instillation for research BAL sampling as in CTOT-20.

• Study Type: Observational
• Enrollment (Actual): 467

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2C4
      • Toronto General Hospital
• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California Los Angeles Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Current CTOT-20 participants

Exclusion Criteria:

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• Withdrawn CTOT-20 participants

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life (QOL) as serially assessed by the Short Form 36 (SF-36)	The SF-36 is a 36 item survey that measures personal views on health and activities of daily living.	Baseline and annually for 2 years
Change in Quality of Life (QOL) as serially assessed by the Saint George's Respiratory Questionnaire	The Saint George's Respiratory Questionnaire is a 2 part questionnaire that measures troubled breathing and the impact on quality of life.	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Cystic Fibrosis Foundation
• Investigators: Principal Investigator: Scott M Palmer, MD, MHS, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Lung transplantation; Chronic lung allograft dysfunction
• Other Study ID Numbers: Pro00102592; PALMER19AB0 (Other Grant/Funding Number: Cystic Fibrosis Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No