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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030472
Receipt No. R000034796
Scientific Title Validation of predictive and prognostic markers in upper gastrointestinal cancer
Date of disclosure of the study information 2017/12/20
Last modified on 2017/12/19

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Basic information
Public title Validation of predictive and prognostic markers in upper gastrointestinal cancer
Acronym Validation of predictive and prognostic markers
Scientific Title Validation of predictive and prognostic markers in upper gastrointestinal cancer
Scientific Title:Acronym Validation of predictive and prognostic markers
Region
Japan

Condition
Condition Upper gastrointestinal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, we examine the utility of biomarkers as a predictor of survival in Upper gastrointestinal cancer
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Cancer-specific survival
Key secondary outcomes Overall survival

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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histopathologically proven gastric cancer
2.20 years of age and older
90 yearrs of age and younger
3.ECOG performance status 0 or 1
4.No previous treatment (chemotherapy, radootherapy) for any cancer in recent 5 years
5.Patients who can take medecine orally
Key exclusion criteria 1.Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma, and multicentric cancer.
2.Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, heart failure, renal failure, liver cirrhosis, liver failure, etc.).
3.Patients with infections.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Hirahara
Organization Shimane University Faculty of Medicine
Division name Department of Digestive and General Surgery
Zip code
Address 89-1 Enya-cho, Izumo Shimane 693-8501
TEL +81-853-20-2232
Email norinori@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Hirahara
Organization Shimane University Faculty of Medicine
Division name Department of Digestive and General Surgery
Zip code
Address 89-1 Enya-cho, Izumo Shimane 693-8501
TEL +81-853-20-2232
Homepage URL
Email norinori@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 20 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 12 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 20 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2025 Year 12 Month 31 Day

Other
Other related information No

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034796

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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