UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023958 |
|---|---|
| Receipt number | R000022219 |
| Scientific Title | A study on the crisis of osteoporosis after gastrectomy for gastric cancer patients |
| Date of disclosure of the study information | 2016/09/07 |
| Last modified on | 2016/09/06 18:33:38 |
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Basic information
Public title
A study on the crisis of osteoporosis after gastrectomy for gastric cancer patients
Acronym
A study on the crisis of osteoporosis after gastrectomy for gastric cancer patients
Scientific Title
A study on the crisis of osteoporosis after gastrectomy for gastric cancer patients
Scientific Title:Acronym
A study on the crisis of osteoporosis after gastrectomy for gastric cancer patients
Region
| Japan |
Condition
Condition
Patients who are scheduled for gastric cancer resection
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of osteoporosis after gastrectomy in patients who are scheduled for gastric cancer resection
Basic objectives2
Others
Basic objectives -Others
To search factors connected to the prevalence of osteoporosis after gastrectomy patients who are scheduled for gastric cancer resection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density at 1year after gastrectomy
Key secondary outcomes
1)Age
2)Sex
3)BMI
4)Information of gastrectomy ;Operative method, Pathological stage, Chemotherapy, Recurrence
5)Complications
6)Medicine
7)Blood test(preparation, 6months, 1year after gastrectomy);TRACP5b, Serum calcium, Serum phosphorus, Serum creatinine, Serum albumen ,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)Patients who are scheduled for gastric cancer resection
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
100
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
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
tsegawa@iwate-med.ac.jp
Sponsor or person
Institute
Department of Surgery, Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Iwate Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 incidence of osteoporosis in gastric-cancer patients with gastrectomy. And we assessed age, sex, body weight loss, tumor staging, operation type, history of chemotherapy, laboratory data, and psoas muscle area, 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
