UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040252 |
|---|---|
| Receipt number | R000045919 |
| Scientific Title | Geriatric assessment in elderly patients undergoing surgical resection of gastric cancer |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/04/27 17:23:04 |
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Basic information
Public title
Geriatric assessment in elderly patients undergoing surgical resection of gastric cancer
Acronym
Geriatric assessment in elderly patients undergoing surgical resection of gastric cancer
Scientific Title
Geriatric assessment in elderly patients undergoing surgical resection of gastric cancer
Scientific Title:Acronym
Geriatric assessment in elderly patients undergoing surgical resection of gastric cancer
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate how surgery affects functions of elderly patients with gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in cognitive function between at the baseline and 6POM because impaired cognition functions after surgery
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically proven gastric adenocarcinoma
2) patients age is > 74
3) a distal gastrectomy (DG) or pylorus-preserving gastrectomy (PPG) or total gastrectomy (TG), or proximal gastrectomy (PG) according to the Japanese Gastric Cancer Treatment Guidelines was planned
4) no severe cognitive function decline 5) written informed consent
Key exclusion criteria
1) other active malignancies
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2250
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Tanaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2250
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate 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
The University Hospital Medical Information Network Clinical Trial Registry
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2973
ethics@med.nagoya-u.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
| 2020 | Year | 05 | Month | 01 | 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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045919
