UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022513 |
|---|---|
| Receipt number | R000025953 |
| Scientific Title | Evaluation of digestive disease by patient reported outcome (PRO) |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/12/04 16:39:11 |
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Basic information
Public title
Evaluation of digestive disease by patient reported outcome (PRO)
Acronym
Evaluation of digestive disease by patient reported outcome (PRO)
Scientific Title
Evaluation of digestive disease by patient reported outcome (PRO)
Scientific Title:Acronym
Evaluation of digestive disease by patient reported outcome (PRO)
Region
| Japan |
Condition
Condition
Gastrointestinal, Liver and Pancreatic Diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the coalition between the QOL scores and clinical scores among the patients with digestive and liver diseases by PRO systems.
To re-evaluate the efficacy about clinical treatment by PRO.
Basic objectives2
Others
Basic objectives -Others
To investigate the coalition between the QOL scores and clinical scores among the patients with digestive and liver diseases by PRO systems.
To re-evaluate the efficacy about clinical treatment by PRO.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coalition between the PRO score and clinical evaluation items.
Comparison of QOL among the patients with different diseases.
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who can respond to the questionnaire sheet of PRO scoring system.
Key exclusion criteria
Other than those above
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya city
TEL
052-744-2172
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Watanabe |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya city
TEL
052-744-2144
Homepage URL
osa-wata@med.nagoya-u.ac.jp
Sponsor or person
Institute
Not applicable
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
| 2016 | Year | 06 | Month | 01 | 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2006 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
