Lung TransplantNCT02631720
CLAD Phenotype Specific Risk Factors and Mechanisms
An observational study of Lung Transplant and Post Lung Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant, Post Lung Transplantation
- What is being tested?
- Blood Draw and Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 884 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Dec 2015to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Who may be able to join
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- 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.
- 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.
- Undergoing first lung transplant operation.
- Transplant surgery to be performed or performed at enrolling center.
- Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Who cannot join
- Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Multi-organ recipient.
- Prior recipients of any solid organ transplant, including prior lung transplant.
- Prior or concurrent recipient of bone marrow transplant.
- HIV infection.
- Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
- Participation in an investigational drug trial at the time of enrollment visit.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
University of California, Los Angeles
Los Angeles, California, 90095
About this study
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)
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
Read the 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.
- Conditions
- Lung Transplant, Post Lung Transplantation
- Being tested
- Blood Draw, Bronchoscopy
- Keywords
- Chronic Lung Allograft Dysfunction (CLAD), Restrictive chronic lung allograft dysfunction (RCLAD), Bronchiolitis Obliterans Syndrome (BOS), CLAD risk factors, observational study
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Also called Phlebotomy, Venipuncture
BronchoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Adult Lung Transplant Recipients | Adult lung transplant recipients undergoing lung transplant at each of the participating centers. Receives: Procedure: Blood Draw; Procedure: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
First occurrence of either phenotype.
Measured: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
Secondary outcomes (2)
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)
Measured: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
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
Measured: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start22 Dec 2015
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 884 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation
- Responsible party
- Sponsor
- Investigators
- Scott M Palmer, MD, MHS, Principal investigator, Duke UniversityJohn Belperio, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631720
- Sponsor's protocol ID
- DAIT CTOT-20
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2015
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Todd JL, Weigt SS, Neely ML, Grau-Sepulveda MV, Mason K, Sever ML, Kesler K, Kirchner J, Frankel CW, Martinu T, Shino MY, Jackson AM, Pavlisko EN, Williams N, Robien MA, Singer LG, Budev M, Tsuang W, Shah PD, Reynolds JM, Snyder LD, Belperio JA, Palmer SM. Prognosis and Risks for Probable Chronic Lung Allograft Dysfunction: A Prospective Multicenter Study. Am J Respir Crit Care Med. 2025 Feb;211(2):239-247. doi: 10.1164/rccm.202403-0568OC.
PubMed 39470452
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02631720
- Acronym / sponsor ID
- DAIT CTOT-20
- Conditions
- Lung Transplant, Post Lung Transplantation
- Keywords
- Chronic Lung Allograft Dysfunction (CLAD), Restrictive chronic lung allograft dysfunction (RCLAD), Bronchiolitis Obliterans Syndrome (BOS), CLAD risk factors, observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 884 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Lung Transplant Recipients | – | Procedure: Blood Draw, Procedure: BronchoscopyAdult lung transplant recipients undergoing lung transplant at each of the participating centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult lung transplant recipients undergoing lung transplant at each of the participating centers.
Key inclusion criteria (8 listed)
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- 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.
- Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.
- Undergoing first lung transplant operation.
Key exclusion criteria (7 listed)
- Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Multi-organ recipient.
- Prior recipients of any solid organ transplant, including prior lung transplant.
- Prior or concurrent recipient of bone marrow transplant.
- HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawAlso: Phlebotomy, Venipuncture | Procedure or surgery | Adult Lung Transplant Recipients |
| Bronchoscopy | Procedure or surgery | Adult Lung Transplant Recipients |
Primary outcome
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.
2 secondary outcomes
Longitudinal Quality of life (QOL) trajectory
Time frame: Baseline until study completion or participant withdrawal (up to 4 years post-transplant)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 39470452Todd JL, Weigt SS, Neely ML, Grau-Sepulveda MV, Mason K, Sever ML, Kesler K, Kirchner J, Frankel CW, Martinu T, Shino MY, Jackson AM, Pavlisko EN, Williams N, Robien MA, Singer LG, Budev M, Tsuang W, Shah PD, Reynolds JM, Snyder LD, Belperio JA, Palmer SM. Prognosis and Risks for Probable Chronic Lung Allograft Dysfunction: A Prospective Multicenter Study. Am J Respir Crit Care Med. 2025 Feb;211(2):239-247. doi: 10.1164/rccm.202403-0568OC.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott M Palmer, MD, MHS principal investigator
Duke University
John Belperio, MD study chair
University of California, Los Angeles
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant and Post Lung Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02631720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.