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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023957
Receipt No. R000022146
Scientific Title An observational study of osteoporosis after gastrectomy in gastric cancer patients
Date of disclosure of the study information 2016/09/07
Last modified on 2016/09/06

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Basic information
Public title An observational study of osteoporosis after gastrectomy in gastric cancer patients
Acronym An observational study of osteoporosis after gastrectomy in gastric cancer patients
Scientific Title An observational study of osteoporosis after gastrectomy in gastric cancer patients
Scientific Title:Acronym An observational study of osteoporosis after gastrectomy in gastric cancer patients
Region
Japan

Condition
Condition Gastric cancer patients who have undergone gastrectomy
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of osteoporosis in gastric cancer patients who have undergone gastrectomy
Basic objectives2 Others
Basic objectives -Others To search factors connected to the prevalence of osteoporosis in gastric cancer patients who have undergone gastrectomy
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Bone mineral density
Key secondary outcomes 1)Age
2)Sex
3)BMI
4)Information of gastrectomy
1.Operative method
2.Pathological stage
3.Chemotherapy
4.Recurrence
5)Complications
6)Medicine
7)Blood test
1.TRACP-5b
2.Serum calcium
3.Serum phosphorus
4.Serum creatinine
5.Serum albumen
6.Hemoglobin

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 1)Gastric cancer patients who have undergone gastrectomy
2)Pathological diagnosis:adenocarcinoma
3)Operative method, Reconstruction:No object
4)Age:more than 20 years old
5)Gender:No object
6)Out patient or inpatient:Out patient
7)Agreement to sign an informed consent
Key exclusion criteria 1)Women are pregnant or able to get pregnant
2)Women are nursing
3)Patients have mortal complications;heart disease, liver or kidney trouble
4)Patients were considered to be inappropriate by the physician
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koeda Keisuke
Organization Iwate Medical University School of Medicine
Division name Department of Surgery
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Email keikoeda@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Segawa Takenori
Organization Iwate Medical University School of Medicine
Division name Department of Surgery
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Homepage URL
Email tsegawa@iwate-med.ac.jp

Sponsor
Institute Department of Surgery, Medical University School of Medicine
Institute
Department

Funding Source
Organization wate Medical University School of Medicine
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 09 Month 07 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study is to survey prevalence of osteoporosis in post-gastrectomy patients. And we assess age, sex, body weight loss, tumor staging, operation type, history of chemotherapy, and laboratory data, and analyzed relation of these factors to osteoporosis and BMD levels.

Management information
Registered date
2016 Year 09 Month 06 Day
Last modified on
2016 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022146

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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