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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033718
Receipt No. R000038449
Scientific Title Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Date of disclosure of the study information 2018/08/30
Last modified on 2018/08/10

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Basic information
Public title Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Acronym Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Scientific Title Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Scientific Title:Acronym Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Region
Japan

Condition
Condition gastrointestinal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a prognostic system for Stage IV esophageal cancer, gastric cancer, and colorectal cancer that can be used by both the primary physician and the patient in community medical care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall all survival
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria StageIV gastrointestinalcancer (esophagus cancer, gastric cancer, colorectal cancer)
Key exclusion criteria case of missing data
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michitaka Honda
Organization Fukushima medical university
Division name Department of minimally invasive surgical and medical oncology
Zip code
Address 7-115 Yatsuyamada, Koriyama, Fukushima
TEL 024-934-5322
Email mhonda1017@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidetaka Kawamura
Organization Fukushima medical university
Division name Department of minimally invasive surgical and medical oncology
Zip code
Address 7-115 Yatsuyamada, Koriyama, Fukushima
TEL 024-934-5322
Homepage URL
Email hidetaka0716.hk@gmail.com

Sponsor
Institute Southern TOHOKU General Hospital
Institute
Department

Funding Source
Organization Southern TOHOKU General Hospital
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
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
2018 Year 08 Month 30 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2018 Year 08 Month 10 Day
Last modified on
2018 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038449

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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