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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036184
Receipt No. R000041224
Scientific Title An obserbational study on physical activity and nutritional status of patients with pancreatobiliary diseases.
Date of disclosure of the study information 2019/06/01
Last modified on 2019/03/13

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Basic information
Public title An obserbational study on physical activity and nutritional status of patients with pancreatobiliary diseases.
Acronym An obserbational study on physical activity and nutritional status of patients with pancreatobiliary diseases.
Scientific Title An obserbational study on physical activity and nutritional status of patients with pancreatobiliary diseases.
Scientific Title:Acronym An obserbational study on physical activity and nutritional status of patients with pancreatobiliary diseases.
Region
Japan

Condition
Condition benign pancreatobiliary diseases
malignant pancreatobiliary diseases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify physical activity and nutritional status of patients with pancreatobiliary diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Energy expenditure
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pancreatobiliary diseases in division of gastroenterology, Tohoku University Hospital
Key exclusion criteria 1) Without the informed consent on this study
2) Judged as being unsuitable for this study by investigators
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Masamune
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Email amasamune@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Kikuta
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code 980-8574
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Homepage URL
Email kkikuta@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan society for the promotion of science
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 Ethics Committee Tohoku University Graduate School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.ac.jp

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
2019 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Obsevbational Study

Management information
Registered date
2019 Year 03 Month 13 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041224

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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