UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044066 |
|---|---|
| Receipt number | R000050315 |
| Scientific Title | Change of intramuscular adipose tissue content after gastric surgery |
| Date of disclosure of the study information | 2021/04/28 |
| Last modified on | 2021/04/28 15:14:35 |
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Basic information
Public title
Change of intramuscular adipose tissue content after gastric surgery
Acronym
IMAC after gastric surgery
Scientific Title
Change of intramuscular adipose tissue content after gastric surgery
Scientific Title:Acronym
IMAC after gastric surgery
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate intramuscular adipose content after gastric surgery
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intramuscular adipose tissue content after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Plain CT
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
| 21 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. histologically diagnosed gastric cancer
2. 21 years old and over
3. plain CT was taken before surgery
4. CT is scheduled between 9 and 15 months after surgery
5. post surgery for gastric cancer
6. informed consent is taken
Key exclusion criteria
1. participating other nutritional or exercise trials
2. under treatment for other advanced gastric cancer
3. insufficient oral intake
4. underwent neoadjuvant chemotherapy
5. inappropriate situation judged by responsible physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Souya |
| Middle name | |
| Last name | Nunobe |
Organization
Ariake Hospital of Japanese Foundation for Cancer Research
Division name
Gastroenterological Surgery
Zip code
135-0063
Address
Ariake 3-8-31
TEL
0335200111
souya.nunobe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Izumi |
Organization
Ariake Hospital of Japanese Foundation for Cancer Research
Division name
Gastroenterological surgery
Zip code
135
Address
Ariake 3-8-31
TEL
0335200111
Homepage URL
daisuke.izumi@jfcr.or.jp
Sponsor or person
Institute
Japanese foundation for cancer research
Institute
Department
Personal name
Funding Source
Organization
Japanese foundation for cancer research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese foundation for cancer research
Address
3-8-31
Tel
0335200111
daisuke.izumi@jfcr.or.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 | 04 | Month | 28 | 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
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050315
| 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 |
