Clinical Trials in Organ Transplantation Extension Study

Active, not recruiting

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.

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
Time from lung transplant to Chronic Lung Allograft Dysfunction (CLAD) (including RCLAD or BOS) as measured by serial pulmonary function tests	Baseline, up to 24 months	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
Number of participants that have Th1, Th2, and Th17 immune profiles as measured in the blood	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

Secondary Outcome Measures

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

Locations (5): Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
University of California Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States