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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022513
Receipt No. 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

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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
Email 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
Email osa-wata@med.nagoya-u.ac.jp

Sponsor
Institute Not applicable
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025953

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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