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Prognosis of Lung Transplant Candidates

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ClinicalTrials.gov Identifier: NCT00905463
Recruitment Status : Recruiting
First Posted : May 20, 2009
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Lung Transplantation Respiratory Failure Procedure: Lung transplantation

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates
Study Start Date : April 2009
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Prognosis/Mortality [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Health status [ Time Frame: At entry and every year for 5 years ]
  2. Dyspnea [ Time Frame: At entry and every year for 5 years ]
  3. Psychological status [ Time Frame: At entry and every year for 5 years ]
  4. Sleep quality [ Time Frame: At entry and every year for 5 years ]
  5. Pulmonary function [ Time Frame: At entry and every year for 5 years ]
  6. Arterial blood gas [ Time Frame: At entry and every year for 5 years ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
University hospital clinic for lung transplantation
Criteria

Inclusion Criteria:

  • New lung transplant candidates

Exclusion Criteria:

  • Heart and lung transplant candidates
  • Uncontrolled severe comorbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905463


Contacts
Contact: Fengshi Chen, MD, PhD +81 75 751 4975 fengshic@kuhp.kyoto-u.ac.jp
Contact: Toru Oga, MD, PhD +81 75 751 3852 ogato@kuhp.kyoto-u.ac.jp

Locations
Japan
Graduate School of Medicine, Kyoto University Recruiting
Kyoto, Japan
Contact: Fengshi Chen, MD, PhD    +81 75 751 4975    fengshic@kuhp.kyoto-u.ac.jp   
Contact: Toru Oga, MD, PhD    +81 75 751 3852    ogato@kuhp.kyoto-u.ac.jp   
Sub-Investigator: Toru Bando, MD         
Sub-Investigator: Izumi Matsumoto         
Sub-Investigator: Hiroaki Sakai, MD         
Okayama University Recruiting
Okayama, Japan
Principal Investigator: Takahiro Oto, MD         
Tohoku University Recruiting
Sendai, Japan
Principal Investigator: Katsunori Okada, M.D.         
Osaka University Recruiting
Suita, Japan
Principal Investigator: Masato Minami, MD         
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Hiroshi Date, MD, PhD Graduate School of Medicine, Kyoto University

Responsible Party: Toru Oga, Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00905463     History of Changes
Other Study ID Numbers: E554kyoto
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016

Keywords provided by Toru Oga, Kyoto University, Graduate School of Medicine:
Lung transplant candidates
Health-related quality of life
patient reported outcome
Prognosis

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases