Prognosis of Lung Transplant Candidates

August 25, 2019 updated by: Toru Oga, Kyoto University, Graduate School of Medicine

Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates

The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Study Type

Observational

Enrollment (Actual)

272

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan
        • Graduate School of Medicine, Kyoto University
      • Okayama, Japan
        • Okayama University
      • Sendai, Japan
        • Tohoku University
      • Suita, Japan
        • Osaka University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

University hospital clinic for lung transplantation

Description

Inclusion Criteria:

  • New lung transplant candidates

Exclusion Criteria:

  • Heart and lung transplant candidates
  • Uncontrolled severe comorbidities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transplantation
Lung transplantation candidates
Procedure: Lung transplantation
Lung transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prognosis/Mortality
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Health status
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Dyspnea
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Psychological status
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Sleep quality
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Pulmonary function
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years
Arterial blood gas
Time Frame: At entry and every year for 5 years
At entry and every year for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Hiroshi Date, MD, PhD, Graduate School of Medicine, Kyoto University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 25, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E554kyoto

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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