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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02631720
Other study ID # DAIT CTOT-20
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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 startā€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.

Study Design


Related Conditions & MeSH terms


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)
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