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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025540
Receipt No. R000029397
Scientific Title Association of cancer-related factors and 5-year survival rate in patients with hepatocellular carcinoma.
Date of disclosure of the study information 2017/01/05
Last modified on 2017/01/10

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Basic information
Public title Association of cancer-related factors and 5-year survival rate in patients with hepatocellular carcinoma.
Acronym The observational retrospective study in patients with hepatocellular carcinoma.
Scientific Title Association of cancer-related factors and 5-year survival rate in patients with hepatocellular carcinoma.
Scientific Title:Acronym The observational retrospective study in patients with hepatocellular carcinoma.
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We aim to evaluate the between cancer-related gene expression and clinical factors, and 5-year survival rate in patients with hepatocellular carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 5-year survival rate
Key secondary outcomes Recurrence and metastasis

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 1)The case that liver tissue specimen are storing St. Marianna University School of Medicine Human Tissue/Specimen Banking for a surgical operation in patients with hepatocellular carcinoma.
2)The patients include more than five years from a surgical operation (before 31 December 2011).
Key exclusion criteria 1)If the patients evaluate single nucleotide polymorphism (SNP), it has not approved the human genome/gene analysis research.
Target sample size 29

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Matsumoto
Organization St. Marianna University School of Medicine
Division name Department of Pharmacology
Zip code
Address 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa
TEL 044-977-8111
Email matsumoto@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daiki Watanabe
Organization St. Marianna University School of Medicine
Division name Department of Pharmacology
Zip code
Address 2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa
TEL 044-977-8111
Homepage URL
Email d2watanabe@marianna-u.ac.jp

Sponsor
Institute Department of Pharmacology, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization None
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
2017 Year 01 Month 05 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
2016 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Predictor variable
1) Protein expression of cancer stem cell markers
2) The mRNA expression of cancer-related genes
3) Nutritional status(Body weight, Controlling Nutritional Status(CONUT), Prognostic Nutritional Index(PNI), Grasgow Prognostic Score, Body Mass Index(BMI) and history of alcohol intake)
4) Single Nucleotide Polymorphism(SNP) of cancer stem cell markers


Management information
Registered date
2017 Year 01 Month 05 Day
Last modified on
2017 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029397

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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