UMIN-CTR Clinical Trial

Basic information
Public title	Registration of patients with gastric cancer in Department of Gastroenterological Surgery, Fukuoka University
Acronym	Registration of patients with gastric cancer in Department of Gastroenterological Surgery, Fukuoka University
Scientific Title	Registration of patients with gastric cancer in Department of Gastroenterological Surgery, Fukuoka University
Scientific Title:Acronym	Registration of patients with gastric cancer in Department of Gastroenterological Surgery, Fukuoka University
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate and analyze the data of registration data of gastric cancer patients treated at Fukuoka University hospital
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complication rate, survival and recurrence rate
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients treated in our hospital between 4/1/2016 - 3/31/2029
Key exclusion criteria	judged as inappropriate for registration by physicial
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Hasegawa
Organization	Faculty of medicine, Fukuoka University
Division name	Dept of Gastroenterological Surgery
Zip code	810-0180
Address	Nanakuma 7-45-1. Jonan, Fukuoka, JPN
TEL	092-801-1011
Email	shase@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Suguru Middle name Last name Hasegawa
Organization	Faculty of Medicine, Fukuoka University
Division name	Dept of Gastroenterological Surgery
Zip code	814-0180
Address	Nanakuma 7-45-1. Jonan, Fukuoka, JPN
TEL	092-801-1011
Homepage URL
Email	shase@fukuoka-u.ac.jp

Sponsor
Institute	Dept of Gastroenterological Surgery Faculty of Medicine, Fukuoka University
Institute
Department

Funding Source
Organization	Dept of Gastroenterological Surgery Faculty of Medicine, Fukuoka University
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	Medical Ethics Committee of Fukuoka University
Address	Nanakuma 7-45-1. Jonan, Fukuoka, JPN
Tel	092-801-1011
Email	fumed-ethics@fukuoka-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	2019 Year 07 Month 04 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	2018 Year 11 Month 16 Day
Date of IRB	2018 Year 11 Month 22 Day
Anticipated trial start date	2018 Year 11 Month 22 Day
Last follow-up date	2034 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	to investigate factors associated with patients survival, prognosis, safety and efficacy of the treatment

Management information
Registered date	2019 Year 07 Month 03 Day
Last modified on	2019 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042475