UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030846 |
|---|---|
| Receipt number | R000035216 |
| Scientific Title | Nutrition-related factors associated with waiting list mortality in patients with interstitial lung disease |
| Date of disclosure of the study information | 2018/01/17 |
| Last modified on | 2018/01/17 09:31:44 |
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Basic information
Public title
Nutrition-related factors associated with waiting list mortality in patients with interstitial lung disease
Acronym
Factors associated with waitlist mortality
Scientific Title
Nutrition-related factors associated with waiting list mortality in patients with interstitial lung disease
Scientific Title:Acronym
Factors associated with waitlist mortality
Region
| Japan |
Condition
Condition
interstitial lung disease
chronic respiratory disease
Classification by specialty
| Pneumology | Chest surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find nutrition-related markers with waiting list mortality
Basic objectives2
Others
Basic objectives -Others
association with wait list mortality and body compositions, serum albumin and serum transthyretin
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to assess the relationship of nutrition-related factors with waiting list mortality
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. interstitial lung disease
Key exclusion criteria
1. severe comorbidities
2. lung transplantation from living donors during hospitalization before registration to JOTN
3. hospitalization for a second lung transplantation
4. registration at another hospital
5. failure to meet the JOTN criteria
6. severe mental disorders
7. alcoholism
8. smoking
9. incomplete data
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Harashima |
Organization
Kyoto University
Division name
Diabetes, Endocrinology and Nutrition
Zip code
Address
54 Shogoin Kawahara-cho Sakyo-ku Kyoto
TEL
0757513560
harasima@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyofumi F. Chen-Yoshikawa |
Organization
Kyoto University
Division name
Thoracic Surgery
Zip code
Address
54 Shogoin Kawahara-cho Sakyo-ku Kyoto
TEL
0757514975
Homepage URL
fengshic@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Seventy-six patients were screened; among them, 48 fulfilled the inclusion criteria.
The final analysis target was 40.
Median observational period was 497 (range 97-1015) days; median survival time was 550 (95% CI 414-686) days.
Mortality rate was 38.7/100 person-years.
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2018 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035216
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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