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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018957
Receipt No. R000021793
Scientific Title Prospective cohort study on bone mineral dencity changes in the Stage 1,2 gastric cancer patients after gastrectomy
Date of disclosure of the study information 2015/09/10
Last modified on 2015/09/15

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Basic information
Public title Prospective cohort study on bone mineral dencity changes in the Stage 1,2 gastric cancer patients after gastrectomy
Acronym Prospective cohort study on bone mineral density changes after gastrectomy (LOHAS study)
Scientific Title Prospective cohort study on bone mineral dencity changes in the Stage 1,2 gastric cancer patients after gastrectomy
Scientific Title:Acronym Prospective cohort study on bone mineral density changes after gastrectomy (LOHAS study)
Region
Japan

Condition
Condition gastric cancer patients with pathological stage 1 and 2
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the bone mineral dencity changes prospectively, in the patients who had gastric resection
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the rate of the bone mineral dencity changes per year
Key secondary outcomes the incidence rate of the new vertebral body fracture,the incidence rate of the fragility fracture,the incidence rate of osteoporosis,P1NP,sNTX,alkaline-phosphatase

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
40 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1. The gastric cancer patients with stage 1 or 2
2. Having a T-score over -2.5 measured by the DXA method within 4 weeks after the gastric resection
3. Patients shall not have medicaland treatment history of osteoporosis
4. Patients shall not have treatment history of Androgen receptor antagonists,Aromatase inhibitor,Insulin,corticosteroid or vitamin D
5. Patients shall not have treatment history of chemotherapy,radiation therapy or any gastric resection
6. Performance Status(ECOG) 0 or 1
7. Written informed consent will be obtained from all patients
Key exclusion criteria 1.Hyperthyroidism,Hypothyroidism
2.Hyperparathyroidism,Hypoparathyroidism
3.Hypocalcemia,Hypercalcemia
4.Rheumatoid arthritis
5.Paget's disease of bone
6.Hyperprolactinemia
7.Chronic liver disease and Cirrhosis
8.Alcoholism
9.Chronic kidney disease and Renal insufficiency
10.Primary amenorrhea,Early menopause and the patients who have history of Oophorectomy before menopause
11.Patients determined to be inappropriate for this study
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Imano
Organization Kinki University Faculty of Medicine
Division name Department of surgery
Zip code
Address 377-2 onohigashi, osaka-sayama city, osaka, Japan
TEL 072-366-0221
Email imano@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Imano
Organization Kinki University Faculty of Medicine
Division name Department of surgery
Zip code
Address 377-2 onohigashi, osaka-sayama city, osaka, Japan
TEL 072-366-0221
Homepage URL
Email imano@med.kindai.ac.jp

Sponsor
Institute Japanese Gastirc cancer association
Institute
Department

Funding Source
Organization none
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 日本胃癌学会関連組織

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 10 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
2015 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 10 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 Study Design: Prospective cohort study

Recruitment: April 2015 to March 2018
Patients registered facility of gastric cancer Society were admitted, and conform to the selection criteria and obtained written informed consent.
Measurable item: bone density change rate, a new vertebral fracture incidence, a new fragility fracture incidence, osteoporosis etc.

Management information
Registered date
2015 Year 09 Month 09 Day
Last modified on
2015 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021793

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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