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CLAD Phenotype Specific Risk Factors and Mechanisms

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ClinicalTrials.gov Identifier: NCT02631720
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
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

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 800 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 five years. Participants will be followed a minimum of 2 and a maximum of 5 years.

Study Type : Observational
Estimated Enrollment : 800 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)
Study Start Date : December 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 5 years post-transplant) ]
    First occurrence of either phenotype.

  2. Chemokine/cytokine Quantification of Type 1 and Type 17 immune profile proteins [ Time Frame: Baseline until study completion or participant withdrawal (up to 5 years post-transplant) ]
    Measured in the Bronchoalveolar lavage (BAL) supernatant.using standard Luminex and ELISA commercial assays


Secondary Outcome Measures :
  1. Longitudinal Quality of life (QOL) trajectory [ Time Frame: Baseline until study completion or participant withdrawal (up to 5 years post-transplant) ]
    As serially assessed by the 36-item Short Form Survey (SF‐36) and the St. George's Respiratory Questionnaire (SGRQ)

  2. Time from transplant to death or retransplant [ Time Frame: Until study completion or participant withdrawal (up to 5 years post-transplant ]
  3. Time from CLAD onset to the occurrence of death or retransplant [ Time Frame: CLAD onset until study completion or participant withdrawal ]
  4. Longitudinal Pulmonary function test (PFT) trajectory [ Time Frame: Baseline until study completion or participant withdrawal (up to 5 years post-transplant) ]
    As assessed by Serial Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC)


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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  2. Anticipated listing for lung transplantation OR listed for lung transplant or is within 1 month of having received a single or bilateral cadaveric donor lung transplant.
  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. Pregnant or planned pregnancy.
  6. Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
  7. Participation in an investigational drug trial at the time of enrollment visit.

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
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Eileen Callahan    310-794-2466    ecallahan@mednet.ucla.edu   
Principal Investigator: John Belperio, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Joby Mathew    410-550-6458    jmathe27@jhmi.edu   
Principal Investigator: Pali Shah, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Allie Frear    919-684-8914    allie.frear@dm.duke.edu   
Principal Investigator: John M Reynolds, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Bette Maierson    216-444-2901    maierse@ccf.org   
Principal Investigator: Marie Budev, DO         
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Anam Islam    (416) 340-4800 ext 6740    anam.islam@uhnresearch.ca   
Principal Investigator: Lianne Singer, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Investigators
Principal Investigator: Scott M Palmer, MD, MHS Duke University
Study Chair: John Belperio, MD University of California, Los Angeles

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02631720     History of Changes
Other Study ID Numbers: DAIT CTOT-20
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

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