CLAD Phenotype Specific Risk Factors and Mechanisms

NCT ID: NCT02631720

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

884 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-22

Study Completion Date

2019-11-30

Brief Summary

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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

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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

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Lung Transplant Post Lung Transplantation

Keywords

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Chronic Lung Allograft Dysfunction (CLAD) Restrictive chronic lung allograft dysfunction (RCLAD) Bronchiolitis Obliterans Syndrome (BOS) CLAD risk factors observational study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult Lung Transplant Recipients

Adult lung transplant recipients undergoing lung transplant at each of the participating centers.

Blood Draw

Intervention Type PROCEDURE

Bronchoscopy

Intervention Type PROCEDURE

Interventions

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Blood Draw

Intervention Type PROCEDURE

Bronchoscopy

Intervention Type PROCEDURE

Other Intervention Names

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Phlebotomy Venipuncture

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Trials in Organ Transplantation

NETWORK

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott M Palmer, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

John Belperio, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 39470452 (View on PubMed)

Related Links

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https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

http://www.ctotstudies.org/

Clinical Trials in Organ Transplantation (CTOT)

Other Identifiers

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DAIT CTOT-20

Identifier Type: -

Identifier Source: org_study_id