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CLAD Phenotype Specific Risk Factors and Mechanisms

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ClinicalTrials.gov Identifier: NCT02631720
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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

Condition or disease Intervention/treatment
Lung Transplant Post Lung Transplantation Procedure: Blood Draw Procedure: Bronchoscopy

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 Design
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Study Type : Observational
Actual Enrollment : 884 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : December 22, 2015
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Adult Lung Transplant Recipients
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
 Procedure: Blood Draw
Other Names:
  • Phlebotomy
  • Venipuncture

Procedure: Bronchoscopy


Outcome Measures
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Primary Outcome Measures :
  1. Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS). [ Time Frame: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant) ]
    First occurrence of either phenotype.


Secondary Outcome Measures :
  1. Longitudinal Quality of life (QOL) trajectory [ Time Frame: 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)

  2. Mechanistic: Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Peripheral whole blood samples: DNA, RNA, Plasma, Serum Bronchoalveolar lavage (BAL): aliquots with DNA, cells, supernatant

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631720


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Investigators
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Principal Investigator: Scott M Palmer, MD, MHS Duke University
Study Chair: John Belperio, MD University of California, Los Angeles
More Information
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Additional Information:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02631720    
Other Study ID Numbers: DAIT CTOT-20
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Chronic Lung Allograft Dysfunction (CLAD)
Restrictive chronic lung allograft dysfunction (RCLAD)
Bronchiolitis Obliterans Syndrome (BOS)
CLAD risk factors
observational study