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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028800
Receipt No. R000032959
Scientific Title Bone structural changes short-term after gastrectomy evaluated by HR-pQCT
Date of disclosure of the study information 2017/09/01
Last modified on 2018/02/24

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Basic information
Public title Bone structural changes short-term after gastrectomy evaluated by HR-pQCT
Acronym Bone structural changes Short-term after gastrectomy evaluated by HR-pQCT
Scientific Title Bone structural changes short-term after gastrectomy evaluated by HR-pQCT
Scientific Title:Acronym Bone structural changes Short-term after gastrectomy evaluated by HR-pQCT
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate changes in the bone architectures as assessed using HR-pQCT before and after several surgical procedure due to gastric cancer.
Basic objectives2 Others
Basic objectives -Others The aim of this study is to evaluate the relationships with sarcopenia and changes in the bone architectures as assessed using HR-pQCT before and after several surgical procedure due to gastric cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of bone architectures as assessed using HR-pQCT due to total gastrectomy, total gastrectomy, and endoscopic resection.
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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Endoscopic submucosal dissection, distal gastrectomy, and total gastrectomy to gastric cancer
2. Age: 50 - 79 years old
3. Gender: male and female
4. Obtaining informed consent
Key exclusion criteria 1. pregnancy
2. continuing treatment to advanced malignant tumor
3. treatment to osteoporosis with teriparatide, denosumab, and bisphosphonate
4. The patients who are not appropriate for this research
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Eguchi
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Surgery
Zip code
Address sakamoto, 1-7-1
TEL 0958197316
Email sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Kobayashi
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Surgery
Zip code
Address sakamoto, 1-7-1, Nagasaki, Japan
TEL 0958197316
Homepage URL
Email shinichirokobayashi@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization a Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
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
2017 Year 09 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2017 Year 08 Month 23 Day
Last modified on
2018 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032959

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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