Lung Transplant Failure and Rejection
Conditions
Keywords
Lung transplantation, Chronic lung allograft dysfunction
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.
Interventions
None listed
Sponsors
Cystic Fibrosis Foundation
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current CTOT-20 participants
Exclusion criteria
* Non-CTOT-20 participants * Withdrawn CTOT-20 participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that have Th1, Th2, and Th17 immune profiles as measured in the blood | Up to 24 months | — |
| 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | — |
Countries
Canada, United States
Outcome results
None listed