This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

CLAD Phenotype Specific Risk Factors and Mechanisms.

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT02631720
First received: December 14, 2015
Last updated: November 23, 2016
Last verified: November 2016
  Purpose

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 Intervention
Lung Transplant Procedure: Blood Draw Procedure: Bronchoscopy

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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.

  • 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:
  • 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)

  • Time from transplant to death or retransplant [ Time Frame: Until study completion or participant withdrawal (up to 5 years post-transplant ]
  • Time from CLAD onset to the occurrence of death or retransplant [ Time Frame: CLAD onset until study completion or participant withdrawal ]
  • 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

Estimated Enrollment: 800
Study Start Date: December 2015
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: December 14, 2015
Last Updated: November 23, 2016

ClinicalTrials.gov processed this record on August 18, 2017