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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013986
Receipt No. R000016294
Scientific Title A cross-sectional study of hepatic cancer screening with abdominal ultrasonography and tumor markers.
Date of disclosure of the study information 2014/06/25
Last modified on 2015/11/18

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Basic information
Public title A cross-sectional study of hepatic cancer screening with abdominal ultrasonography and tumor markers.
Acronym A cross-sectional study of hepatic cancer screening.
Scientific Title A cross-sectional study of hepatic cancer screening with abdominal ultrasonography and tumor markers.
Scientific Title:Acronym A cross-sectional study of hepatic cancer screening.
Region
Japan

Condition
Condition hepatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of hepatic cancer screening with abdominal ultrasonography and tumor markers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence rate of hepatic caner.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Residents in the
study area.
Key exclusion criteria Residents out of the study area.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Sugihara
Organization Tottori University Faculty of Medicine

Division name Medicine and Clinical Science
Zip code
Address 36-1 Nishimachi, Yonago
TEL 0859-38-6527
Email sugitaka@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaaki Sugihara
Organization Tottori University Faculty of Medicine
Division name Medicine and Clinical Science
Zip code
Address 36-1 Nishimachi, Yonago
TEL 0859-38-6527
Homepage URL
Email sugitaka@med.tottori-u.ac.jp

Sponsor
Institute Division of Medicine and Clinical Science
,Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization Tottori prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor Tottori University
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
2014 Year 06 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results One case of hepatocellular carcinoma was detected in this study.
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 Completed
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information Obtain participants' information (Age, Sex, body weight, BMI, degree of alcohol intake and smoking etc.) by interview and measurement. And take blood samples for examine liver enzymes (AST, ALT, GGT) and tumor markers (AFP, DCP). Then abdominal ultrasonography and elastography will be performed.

Management information
Registered date
2014 Year 05 Month 18 Day
Last modified on
2015 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016294

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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