CLAD Phenotype Specific Risk Factors and Mechanisms

Lung Transplant Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631720
• Other study ID #: DAIT CTOT-20
• Status: Completed
• Start date: December 22, 2015
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 884
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplant
• Post Lung Transplantation

Intervention

Procedure:
• Blood Draw

• Bronchoscopy

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	Johns Hopkins University	Baltimore	Maryland
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).	First occurrence of either phenotype.	90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
Secondary	Longitudinal Quality of life (QOL) trajectory	As serially assessed by the 36-item Short Form Survey (SF-36) and the St. George's Respiratory Questionnaire (SGRQ)	Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
Secondary	Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins	Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays	Baseline until study completion or participant withdrawal (up to 4 years post-transplant)

External Links

•   Clinical Trials in Organ Transplantation (CTOT)
•   Division of Allergy, Immunology, and Transplantation (DAIT)
•   National Institute of Allergy and Infectious Diseases (NIAID)