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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030111
Receipt No. R000034380
Scientific Title A prospective observation study of biomarkers to predict patterns of recurrence after curative surgery for gastric cancer
Date of disclosure of the study information 2017/11/24
Last modified on 2019/05/27

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Basic information
Public title A prospective observation study of biomarkers to predict patterns of recurrence after curative surgery for gastric cancer
Acronym Biomarkers to predict recurrent patterns of gastric cancer
Scientific Title A prospective observation study of biomarkers to predict patterns of recurrence after curative surgery for gastric cancer
Scientific Title:Acronym Biomarkers to predict recurrent patterns of gastric cancer
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this prospective observation study was to identify biomarkers to predict patterns of recurrence after curative surgery for gastric cancer.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between expression levels of candidate markers and recurrent patterns of gastric cancer
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 Gastric cancer
Aged 20 years or older
Informed consent
Key exclusion criteria Any condition that makes the patient unsuitable for inclusion in the study according to the investigators
Target sample size 300

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 (Surgery II)
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2249
Email m-kanda@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Mitsuro
Middle name
Last name Kanda
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterological Surgery (Surgery II)
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2249
Homepage URL
Email m-kanda@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
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 Nagoya University Ethics Review Committee
Address 65 Tsurumai-cho,Showa-ku,Nagoya
Tel 052-744-2479
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
2017 Year 11 Month 24 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
2017 Year 11 Month 09 Day
Date of IRB
2017 Year 11 Month 09 Day
Anticipated trial start date
2017 Year 11 Month 27 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Expression analyses using surgical specimes from patients with gastric cancer are conduceted by quantitative PCR and immunohistochemistry.

Management information
Registered date
2017 Year 11 Month 24 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034380

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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