UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024590 |
|---|---|
| Receipt number | R000028300 |
| Scientific Title | The investiaton of comprehenve genetic mutation in patients with HCC and hepatitis. |
| Date of disclosure of the study information | 2016/10/27 |
| Last modified on | 2016/10/27 14:37:22 |
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Basic information
Public title
The investiaton of comprehenve genetic mutation in patients with HCC and hepatitis.
Acronym
The investiaton of comprehenve genetic mutation in patients with HCC and hepatitis.
Scientific Title
The investiaton of comprehenve genetic mutation in patients with HCC and hepatitis.
Scientific Title:Acronym
The investiaton of comprehenve genetic mutation in patients with HCC and hepatitis.
Region
| Japan |
Condition
Condition
HCC/hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clatify the genetic mutation of the patients with HCC and hepatitis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The genetic mutation of Tumor, Non tumor, buffy coat, plasma in patients with HCC and hepatitis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
We collect DNA from tumor, non-tumor, buffy coat, plasma.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who conntract HCC or hepatitis
Key exclusion criteria
women who are pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuro Kanda |
Organization
Chiba university
Division name
Department of gastroenterology
Zip code
Address
1 8 1 Inohana Cyuo ward Chiba city
TEL
043-222-7171
kandat-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuro Kanda |
Organization
Chiba university
Division name
gastroenterology and neohrology
Zip code
Address
1 8 1 Inohana Cyuo ward Chiba city
TEL
043-222-7171
Homepage URL
kandat-cib@umin.ac.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Chiba university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2016 | Year | 10 | Month | 27 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028300
