Clinical Trials in Organ Transplantation Extension Study

Lung Transplant Failure and Rejection Clinical Trial

— CTOT-ES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04126746
• Other study ID #: Pro00102592
• Secondary ID: PALMER19AB0
• Status: Active, not recruiting
• Start date: December 17, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 467
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current CTOT-20 participants

Exclusion Criteria:

• Non-CTOT-20 participants

• Withdrawn CTOT-20 participants

Related Conditions & MeSH terms

• Lung Transplant Failure and Rejection

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	Johns Hopkins University	Baltimore	Maryland
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California Los Angeles Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Cystic Fibrosis Foundation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants that develop CLAD as measured by change in pulmonary function and Physician Adjudication		Up to 24 months
Primary	Number of participants that have Th1, Th2, Th17 immune profiles as measured in the lung fluid		Up to 24 months
Primary	Number of participants that have Th1, Th2, and Th17 immune profiles as measured in the blood		Up to 24 months
Secondary	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
Secondary	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
Secondary	Time from CLAD onset to death as measured by medical record review		Up to 24 months
Secondary	Time from CLAD onset to retransplant as measured by medical record review		Up to 24 months