Lung TransplantationNCT00905697
Patient Reported Outcomes in Living Donor Lung Transplantation
An observational study of Lung Transplantation, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
The purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Living donor lung transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2009to Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kyoto University Hospital Clinic for Lung Transplantation
Who may be able to join
- New donors for living donor lung transplantation
Who cannot join
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation
The purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.
Read the detailed description
In Japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. However, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. Therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.
- Conditions
- Lung Transplantation
- Being tested
- Living donor lung transplantation
- Keywords
- Living donor lung transplantation, Health-related quality of life, Prognosis, Patient reported outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living donor lung transplantationProcedure or surgery
Living donor lung transplantation
| Study group | Role | What they receive |
|---|---|---|
| Living donor lung transplantation | Living lung transplantation donors Receives: Procedure: Living donor lung transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health status
Measured: At entry and every year for 5 years
Secondary outcomes (4)
Change in dyspnea
Measured: At entry and every year for 5 years
Change in psychological status
Measured: At entry and every year for 5 years
Change in sleep quality
Measured: At entry and every year for 5 years
Prognosis
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 completionAug 2019
- Study completionAug 2019
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
- 40 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
- NCT00905697
- Sponsor's protocol ID
- E561kyoto
- 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 Patient Reported Outcomes in Living Donor Lung Transplantation
- ClinicalTrials.gov ID
- NCT00905697
- Acronym / sponsor ID
- E561kyoto
- Conditions
- Lung Transplantation
- Keywords
- Living donor lung transplantation, Health-related quality of life, Prognosis, Patient reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 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
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- 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 purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.
Detailed description
In Japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. However, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. Therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living donor lung transplantation | – | Procedure: Living donor lung transplantationLiving lung transplantation donors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kyoto University Hospital Clinic for Lung Transplantation
Key inclusion criteria (1 listed)
- New donors for living donor lung transplantation
Key exclusion criteria (1 listed)
- Inability to obtain informed consent
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 |
|---|---|---|
| Living donor lung transplantationLiving donor lung transplantation | Procedure or surgery | Living donor lung transplantation |
Primary outcome
Change in health status
Time frame: At entry and every year for 5 years
4 secondary outcomes
Change in dyspnea
Time frame: At entry and every year for 5 years
Change in psychological status
Time frame: At entry and every year for 5 years
Change in sleep quality
Time frame: At entry and every year for 5 years
Prognosis
Time frame: At entry and every year for 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
1 site 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, run by Kyoto University, Graduate School of Medicine at 1 site 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 1 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in health status (time frame: At entry and every year for 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.