UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	department of ganstoenterology and hepatology Okayama university graduate school of medicine dentistry and pharmaceutical science
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012808