CLAD Phenotype Specific Risk Factors and Mechanisms

Completed

• Conditions: Post Lung Transplantation; Lung Transplant
• Interventions: Procedure: Blood Draw; Procedure: Bronchoscopy

• Registration Number: NCT02631720
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-16
• Study Start: 2015-12-22
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 884

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult Lung Transplant Recipients	Blood Draw	Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Adult Lung Transplant Recipients	Bronchoscopy	Adult lung transplant recipients undergoing lung transplant at each of the participating centers.

Primary Outcome Measures

Name	Time	Method
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).	90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)	First occurrence of either phenotype.

Secondary Outcome Measures

Name	Time	Method
Longitudinal Quality of life (QOL) trajectory	Baseline until study completion or participant withdrawal (up to 4 years post-transplant)	As serially assessed by the 36-item Short Form Survey (SF-36) and the St. George's Respiratory Questionnaire (SGRQ)
Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins	Baseline until study completion or participant withdrawal (up to 4 years post-transplant)	Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays

Trial Locations

Locations (5)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada