Clinical Trials in Organ Transplantation Extension Study (CTOT-ES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 5
- 主要终点
- Time from lung transplant to Chronic Lung Allograft Dysfunction (CLAD) (including RCLAD or BOS) as measured by serial pulmonary function tests
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current CTOT-20 participants
排除标准
- •Non-CTOT-20 participants
- •Withdrawn CTOT-20 participants
结局指标
主要结局
Time from lung transplant to Chronic Lung Allograft Dysfunction (CLAD) (including RCLAD or BOS) as measured by serial pulmonary function tests
时间窗: 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
时间窗: Up to 24 months
Number of participants that develop CLAD as measured by change in pulmonary function and Physician Adjudication
时间窗: Up to 24 months
Number of participants that have Th1, Th2, Th17 immune profiles as measured in the lung fluid
时间窗: Up to 24 months
次要结局
- 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)
- Change in Quality of Life (QOL) as serially assessed by the Saint George's Respiratory Questionnaire(Baseline and annually for 2 years)