NCT02631720

CLAD Phenotype Specific Risk Factors and Mechanisms

A Prospective Multicenter Observational Cohort Study to Define the Risks Factors, Mechanisms, and Manifestations of Chronic Lung Allograft Dysfunction (CLAD) Phenotypes (CTOT-20)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 884 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
PROCEDURE	Blood Draw
PROCEDURE	Bronchoscopy

Timeline

• Start date: 2015-12-22
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2015-12-16
• Last updated: 2019-12-17

Locations

5 sites across 2 countries: United States, Canada