Skip to main content
OpenTrials
Completed

NCT Number: NCT04126746

Clinical Trials in Organ Transplantation Extension Study

The purpose of the study is to continue to follow subjects who were enrolled in the CTOT-20 CLAD Phenotypes study. Subjects will provide clinical data and complete quality of life questionnaires that will be used to determine the clinical factors associated with the development of Chronic Lung Allograft Dysfunction (CLAD) after lung transplant.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Transplant Failure and Rejection Behavior Rejection, Psychology Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto General Hospital, Toronto, Ontario, Canada

Loading trial locations.

About this study

There are no mandated study visits, rather the study will be conducted using real world data collected as part of usual clinical care according to the standard of care transplant protocols at each site. Specimens and study data will be collected during standard of care visits and study coordinators will review medical records and extract available clinical data every 6 months. Study coordinators will collect Pulmonary Function Test data that will be transferred to the Data Coordinating Center as in CTOT-20. Subjects will be asked to complete quality of life questionnaires on an annual basis.

The majority of times, blood samples will be collected during clinical care routine venipuncture based on clinic visit scheduling. In the rare circumstances in which research blood is missed during a standard of care venipuncture or one is not scheduled, a participant may be asked to undergo venipuncture for study purposes.

Standard of care (SOC) bronchoscopies with collection of Bronchoalveolar Lavage (BAL) lung fluid will be performed at each center according to clinical management protocols. During SOC bronchoscopies, research participants will undergo additional fluid instillation for research BAL sampling as in CTOT-20.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current CTOT-20 participants

Exclusion criteria

  • Non-CTOT-20 participants
  • Withdrawn CTOT-20 participants

Treatment and study plan

Primary outcomes

  1. Time from lung transplant to Chronic Lung Allograft Dysfunction (CLAD) (including RCLAD or BOS) as measured by serial pulmonary function tests

    Time frame: Baseline, up to 24 months

    Time from lung transplant to the development of CLAD (Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS) as measured by a change in pulmonary function and Physician Adjudication

  2. Number of participants that develop CLAD as measured by change in pulmonary function and Physician Adjudication

    Time frame: Up to 24 months

  3. Number of participants that have Th1, Th2, Th17 immune profiles as measured in the lung fluid

    Time frame: Up to 24 months

  4. Number of participants that have Th1, Th2, and Th17 immune profiles as measured in the blood

    Time frame: Up to 24 months

Secondary outcomes

  1. Change in Quality of Life (QOL) as serially assessed by the Short Form 36 (SF-36)

    Time frame: Baseline and annually for 2 years

    The SF-36 is a 36 item survey that measures personal views on health and activities of daily living.

  2. Change in Quality of Life (QOL) as serially assessed by the Saint George's Respiratory Questionnaire

    Time frame: Baseline and annually for 2 years

    The Saint George's Respiratory Questionnaire is a 2 part questionnaire that measures troubled breathing and the impact on quality of life.

  3. Time from CLAD onset to death as measured by medical record review

    Time frame: Up to 24 months

  4. Time from CLAD onset to retransplant as measured by medical record review

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

Clinical Trials in Organ Transplantation Extension Study (CTOT-ES)

Acronym: CTOT-ES

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2019
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.