UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010943 |
|---|---|
| Receipt number | R000012808 |
| Scientific Title | Analysis of the association of serum cytokeratin-7 with hepato-pancreato-biliary malignancies |
| Date of disclosure of the study information | 2013/06/12 |
| Last modified on | 2021/04/23 07:31:36 |
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Basic information
Public title
Analysis of the association of serum cytokeratin-7 with hepato-pancreato-biliary malignancies
Acronym
serum cytokeratin-7 and hepato-pancreato-biliary malignancies
Scientific Title
Analysis of the association of serum cytokeratin-7 with hepato-pancreato-biliary malignancies
Scientific Title:Acronym
serum cytokeratin-7 and hepato-pancreato-biliary malignancies
Region
| Japan |
Condition
Condition
hepato-pancreato-biliary malignancies
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analize the association of serum cytokeratin-7 with hepato-pancreato-biliary malignancies
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
over 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with hepato-pancreato-biliary malignancies
Key exclusion criteria
none
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikeda Fusao |
Organization
Okayama university graduate school of medicine dentistry and pharmaceutical science
Division name
ganstoenterology and hepatology
Zip code
Address
2-5-1 shikata-cho okayama
TEL
086-235-7219
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikeda Fusao |
Organization
Okayama university graduate school of medicine dentistry and pharmaceutical science
Division name
ganstoenterology and hepatology
Zip code
Address
2-5-1 shikata-cho okayama
TEL
Homepage URL
Sponsor or person
Institute
department of ganstoenterology and hepatology
Okayama university graduate school of medicine dentistry and pharmaceutical science
Institute
Department
Personal name
Funding Source
Organization
Okayama university graduate school of medicine dentistry and pharmaceutical science
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 06 | Month | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2013 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012808
