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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000022063
Receipt No. R000025432
Scientific Title A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2020/10/28

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Basic information
Public title A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Acronym Serum miRNA panel in the diagnosis of pancreatobiliary cancer
Scientific Title A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer
Scientific Title:Acronym Serum miRNA panel in the diagnosis of pancreatobiliary cancer
Region
Japan

Condition
Condition Pancreatobiliary cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the diagnostic value of serum microRNA panel versus CA19-9 in pancreatic and biliary tract cancer, prospectively
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1. In discriminating pancreatobiliary cancer from healthy control, non-inferiority of specificity of serum miRNA panel when comparing the reported CA19-9 data (90-95%) and superiority of sensitivity of serum miRNA panel when comparing CA19-9
2. In discriminating pancreatobiliary cancer from inflammatory pancreatobiliary disease, non-inferiority of sensitivity of serum miRNA panel when comparing the reported CA19-9 data (70-80%) and superiority of specificity of serum miRNA panel when comparing CA19-9
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria healty subjects, patients with inflammatory pancreatobiliary disease, or patients with pancreatobiliary cancer or gastrointestinal cancer
Key exclusion criteria patients with inflammatory pancreatobiliary disease and malignant disease, patients with anti-cancer treatment for cancer
Target sample size 1280

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Mitsunaga
Organization National Cancer Center Hospital East
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Chiba
TEL +81-7133-1111
Email mokojima@east.ncc.go.jp

Public contact
Name of contact person
1st name Shuichi
Middle name
Last name Mitsunaga
Organization National Cancer Center Hospital East
Division name Deparment of Hepatobiliary and Pancreatic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Chiba
TEL +81-7133-1111
Homepage URL
Email smitsuna@east.ncc.go.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1 Tsukiji, Chuo-kuTokyo, 104-0045 Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.jp

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 07 Month 01 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 Suspended
Date of protocol fixation
2016 Year 04 Month 18 Day
Date of IRB
2020 Year 01 Month 22 Day
Anticipated trial start date
2020 Year 02 Month 28 Day
Last follow-up date
2020 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 06 Month 19 Day

Other
Other related information Trial registration was resumed in 2018.

Management information
Registered date
2016 Year 04 Month 25 Day
Last modified on
2020 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025432

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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