UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An observational study of osteoporosis after gastrectomy in gastric cancer patients
Title of the study (Brief title)	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	Koeda Keisuke
Organization	Iwate Medical University School of Medicine
Division name	Department of Surgery
Address	19-1, Uchimaru, Morioka, Iwate
TEL	019-651-5111
Email	keikoeda@iwate-med.ac.jp

Public contact
Name of contact person	Segawa Takenori
Organization	Iwate Medical University School of Medicine
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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