UMIN-CTR Clinical Trial

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
Email	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
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045919