NCT00905463

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

12.9 years

First QC Date

May 18, 2009

Last Update Submit

August 25, 2019

Conditions

Lung TransplantationRespiratory Failure

Keywords

Lung transplant candidatesHealth-related quality of lifepatient reported outcomePrognosis

Outcome Measures

Primary Outcomes (1)

  • Prognosis/Mortality

    5 years

Secondary Outcomes (6)

  • Health status

    At entry and every year for 5 years

  • Dyspnea

    At entry and every year for 5 years

  • Psychological status

    At entry and every year for 5 years

  • Sleep quality

    At entry and every year for 5 years

  • Pulmonary function

    At entry and every year for 5 years

  • +1 more secondary outcomes

Study Arms (1)

Transplantation

Lung transplantation candidates

Procedure: Lung transplantation

Interventions

Lung transplantationPROCEDURE

Lung transplantation

Transplantation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University hospital clinic for lung transplantation

You may qualify if:

  • New lung transplant candidates

You may not qualify if:

  • Heart and lung transplant candidates
  • Uncontrolled severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Graduate School of Medicine, Kyoto University

Kyoto, Japan

Location

Okayama University

Okayama, Japan

Location

Tohoku University

Sendai, Japan

Location

Osaka University

Suita, Japan

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Lung Transplantation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pulmonary Surgical ProceduresThoracic Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Hiroshi Date, MD, PhD

    Graduate School of Medicine, Kyoto University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

JP(4)