Lung TransplantationNCT00905463
Prognosis of Lung Transplant Candidates
An observational study of Lung Transplantation and Respiratory Failure, run by Kyoto University, Graduate School of Medicine at 4 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Transplantation, Respiratory Failure
- What is being tested?
- Lung transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 272 participants
- Where
- 4 sitesJapan
- Study dates
- Apr 2009to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: University hospital clinic for lung transplantation
Who may be able to join
- New lung transplant candidates
Who cannot join
- Heart and lung transplant candidates
- Uncontrolled severe comorbidities
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Graduate School of Medicine, Kyoto University
Kyoto
Okayama University
Okayama
Tohoku University
Sendai
Osaka University
Suita
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Transplantation, Respiratory Failure
- Being tested
- Lung transplantation
- Keywords
- Lung transplant candidates, Health-related quality of life, patient reported outcome, Prognosis
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung transplantationProcedure or surgery
Lung transplantation
| Study group | Role | What they receive |
|---|---|---|
| Transplantation | Lung transplantation candidates Receives: Procedure: Lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognosis/Mortality
Measured: 5 years
Secondary outcomes (6)
Health status
Measured: At entry and every year for 5 years
Dyspnea
Measured: At entry and every year for 5 years
Psychological status
Measured: At entry and every year for 5 years
Sleep quality
Measured: At entry and every year for 5 years
Pulmonary function
Measured: At entry and every year for 5 years
Arterial blood gas
Measured: At entry and every year for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Principal investigator, Toru Oga, Kyoto University, Graduate School of Medicine
- Investigators
- Hiroshi Date, MD, PhD, Study chair, Graduate School of Medicine, Kyoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905463
- Sponsor's protocol ID
- E554kyoto
- Status last verified
- Aug 2019
- First submitted
- 18 May 2009
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates
- ClinicalTrials.gov ID
- NCT00905463
- Acronym / sponsor ID
- E554kyoto
- Conditions
- Lung Transplantation, Respiratory Failure
- Keywords
- Lung transplant candidates, Health-related quality of life, patient reported outcome, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Apr 2009
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 20 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplantation | – | Procedure: Lung transplantationLung transplantation candidates |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- University hospital clinic for lung transplantation
Key inclusion criteria (1 listed)
- New lung transplant candidates
Key exclusion criteria (2 listed)
- Heart and lung transplant candidates
- Uncontrolled severe comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung transplantationLung transplantation | Procedure or surgery | Transplantation |
Primary outcome
Prognosis/Mortality
Time frame: 5 years
6 secondary outcomes
Health status
Time frame: At entry and every year for 5 years
Dyspnea
Time frame: At entry and every year for 5 years
Psychological status
Time frame: At entry and every year for 5 years
Sleep quality
Time frame: At entry and every year for 5 years
Pulmonary function
Time frame: At entry and every year for 5 years
Arterial blood gas
Time frame: At entry and every year for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroshi Date, MD, PhD study chair
Graduate School of Medicine, Kyoto University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Respiratory Failure, run by Kyoto University, Graduate School of Medicine at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognosis/Mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.