Clinical trial NCT02631720: CLAD Phenotype Specific Risk Factors and Mechanisms
Official title: A Prospective Multicenter Observational Cohort Study to Define the Risks Factors, Mechanisms, and Manifestations of Chronic Lung Allograft Dysfunction (CLAD) Phenotypes (CTOT-20)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant
Post Lung Transplantation
Keywords: Chronic Lung Allograft Dysfunction (CLAD)
Restrictive chronic lung allograft dysfunction (RCLAD)
Bronchiolitis Obliterans Syndrome (BOS)
CLAD risk factors
observational study
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation
First posted: 2015-12-16
Enrollment: 884
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult lung transplant recipients undergoing lung transplant at each of the participating centers.

Brief summary: While many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. In this study doctors are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation.

The purpose of this study is to help doctors determine:

* why some people get CLAD and others do not
* how patients who get CLAD do after CLAD is diagnosed
* how CLAD may affect quality of life

Detailed description: This is an observational, prospective, multicenter study of newly transplanted adult, first lung transplant recipients that will collect longitudinal clinical data, patient reported quality of life (QOL) data, and serial biological samples to determine the risk factors, pathophysiology, and manifestations of restrictive chronic lung allograft dysfunction (RCLAD) and bronchiolitis obliterans syndrome (BOS). Anticipated participant accrual is within three years of study start-up. The total study duration is four years. Participants will be followed a minimum of 1 and a maximum of 4 years.

Eligibility criteria: Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study participants:

1. Subject must be able to understand and provide written informed consent and

   -Must be ≥18 years of age at the time of written informed consent.
2. Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.

   - Enrollment must occur prior to the start of bronchoscopies eligible for research bronchoalveolar lavage (BAL) sampling.
3. Undergoing first lung transplant operation.
4. Transplant surgery to be performed or performed at enrolling center.

   * Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for enrollment as study participants:

1. Multi-organ recipient.
2. Prior recipients of any solid organ transplant, including prior lung transplant.
3. Prior or concurrent recipient of bone marrow transplant.
4. HIV infection.
5. Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
6. Participation in an investigational drug trial at the time of enrollment visit.

Primary outcomes:
measure: Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
timeFrame: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
Secondary outcomes:
measure: Longitudinal Quality of life (QOL) trajectory
timeFrame: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
measure: Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins
timeFrame: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: Duke University
name: Scott M Palmer, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: John Belperio, MD
role: STUDY_CHAIR
References: