UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bone structural changes long-term after gastrectomy evaluated by HR-pQCT
Title of the study (Brief title)	Bone structural changes long-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, more than 5 years after gastrectomy and correlate them to changes in selected biochemical markers.
Basic objectives2	Others
Basic objectives -Others	The bone architectures more than 5 years after gastrectomy are compared with case matched selected peoples without gastrectomy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of bone architectures as assessed using HR-pQCT
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	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Survivers 5 years after subtotal and total gastrectomy to gastric cancer 2. Age: 60 - 90 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	114

Research contact person
Name of lead principal investigator	Susumu Eguchi
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Surgery
Address	sakamoto 1-7-1, Nagasaki city
TEL	095-819-7316
Email	sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person	Shinichiro Kobayashi
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Surgery
Address	sakamoto 1-7-1, Nagasaki city
TEL	095-819-7316
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)

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 06 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observational study

Management information
Registered date	2017 Year 06 Month 25 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=R000031990