Clinical trial NCT04126746: Clinical Trials in Organ Transplantation Extension Study
Official title: Clinical Trials in Organ Transplantation Extension Study (CTOT-ES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant Failure and Rejection
Keywords: Lung transplantation
Chronic lung allograft dysfunction
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2019-10-15
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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participants previously enrolled in the CTOT-20 study who are alive and remain active in the study (i.e. not previously withdrawn).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.

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.

Eligibility criteria: Inclusion Criteria:

* Current CTOT-20 participants

Exclusion Criteria:

* Non-CTOT-20 participants
* Withdrawn CTOT-20 participants

Primary outcomes:
measure: Time from lung transplant to Chronic Lung Allograft Dysfunction (CLAD) (including RCLAD or BOS) as measured by serial pulmonary function tests
timeFrame: Baseline, up to 24 months
measure: Number of participants that develop CLAD as measured by change in pulmonary function and Physician Adjudication
timeFrame: Up to 24 months
measure: Number of participants that have Th1, Th2, Th17 immune profiles as measured in the lung fluid
timeFrame: Up to 24 months
measure: Number of participants that have Th1, Th2, and Th17 immune profiles as measured in the blood
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change in Quality of Life (QOL) as serially assessed by the Short Form 36 (SF-36)
timeFrame: Baseline and annually for 2 years
measure: Change in Quality of Life (QOL) as serially assessed by the Saint George's Respiratory Questionnaire
timeFrame: Baseline and annually for 2 years
measure: Time from CLAD onset to death as measured by medical record review
timeFrame: Up to 24 months
measure: Time from CLAD onset to retransplant as measured by medical record review
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Duke University
name: Scott M Palmer, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: