UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013986 |
|---|---|
| Receipt number | 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 10:32:13 |
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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
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
sugitaka@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Medicine and Clinical Science
,Tottori University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
