UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043647 |
|---|---|
| Receipt number | R000049844 |
| Scientific Title | Long term follow-up protocol of prospective cohort study on bone mineral density changes in the stage 1 or 2 gastric cancer patients after gastrectomy |
| Date of disclosure of the study information | 2021/03/17 |
| Last modified on | 2021/03/17 16:46:02 |
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Basic information
Public title
Long term follow-up protocol of prospective cohort study on bone mineral density changes in the stage 1 or 2 gastric cancer patients after gastrectomy
Acronym
Long term follow-up of LOHAS Study
Scientific Title
Long term follow-up protocol of prospective cohort study on bone mineral density changes in the stage 1 or 2 gastric cancer patients after gastrectomy
Scientific Title:Acronym
Long term follow-up of LOHAS Study
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the bone mineral density changes in the patients who had gastrectomy after 5 years
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate of the bone mineral density changes per year
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients enrolled in LOHAS Study and do not fall under the any criteria for discontinuing LOHAS Study
Key exclusion criteria
The patients who fall under the any of criteria for discontinuing LOHAS Study
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Imano |
Organization
Kindai University
Division name
Department of Surgery
Zip code
5898511
Address
377-2, Ono-higashi, Osaka sayama city, Osaka
TEL
0723660221
imano@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Imano |
Organization
Kindai University
Division name
Department of Surgery
Zip code
5898511
Address
377-2, Ono-higashi, Osaka sayama city, Osaka
TEL
0723660221
Homepage URL
imano@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
NA
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
Kindai University
Address
377-2, Ono-higashi, Osaka sayama city, Osaka
Tel
0723660221
imano@med.kindai.ac.jp
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
| 2021 | Year | 03 | Month | 17 | 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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2021 | Year | 03 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049844
