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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014691
Receipt No. R000016870
Scientific Title Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Date of disclosure of the study information 2014/07/30
Last modified on 2019/02/21

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Basic information
Public title Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Acronym Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Scientific Title Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Scientific Title:Acronym Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Region
Japan

Condition
Condition Patients diagnosed or suspected as liver cancer, pancreatic cancer and biliary cancer
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect cell-free nucleic acids in the blood from patients with malignancy and investigate its efficacy as biomarkers for screening, therapy evaluation and prognostic prediction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the clinical utility of cell-free nucleic acids in the blood.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who diagnosed or suspected as liver cancer, pancreatic cancer and biliary cancer
Key exclusion criteria Patients without informed consent.
Target sample size 600

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Minoru Kitago
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL 03-5363-3802
Email contact@keio-hpbts.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Minoru Kitago
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL 03-5363-3802
Homepage URL
Email contact@keio-hpbts.jp

Sponsor
Institute Department of Surgery, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 07 Month 30 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 No longer recruiting
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No aprreciable matter.

Management information
Registered date
2014 Year 07 Month 28 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016870

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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