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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044036
Receipt No. R000050283
Scientific Title The diagnosis of a pancreatic or biliary tract lesion with cell-free DNA in pancreatic juice or bile
Date of disclosure of the study information 2021/04/26
Last modified on 2021/04/26

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Basic information
Public title The diagnosis of a pancreatic or biliary tract lesion with cell-free DNA in pancreatic juice or bile
Acronym Diagnosis of a pancreatic or biliary tract lesion with cell-free DNA
Scientific Title The diagnosis of a pancreatic or biliary tract lesion with cell-free DNA in pancreatic juice or bile
Scientific Title:Acronym Diagnosis of a pancreatic or biliary tract lesion with cell-free DNA
Region
Japan

Condition
Condition Pancreaticobiliary diseases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To clarify the efficacy of cfDNA analysis in pancreatic juice and bile for the diagnosis of pancreaticobiliary lesions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The sensitivity, specificity and accuracy of cfDNA analysis for malignancy
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 (1) Patients with pancreatic or bile duct stricture who require ERCP-related procedures
(2) Patients who provided informed consent
Key exclusion criteria (1) Patients in which appropriate samples are not obtained
(2) Patients who are judged by the principal investigator to be inappropriate as research subjects
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Kuwatani
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code 060-8648
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-176-1161
Email mkuwatan@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Kuwatani
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code 060-8648
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email mkuwatan@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization None
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 Hokkaido University Hospital Institutional Review Board
Address North 14, West 5, Kita-ku, Sapporo
Tel 011-716-1161
Email crjimu@huhp.hokuda.ac.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
2021 Year 04 Month 26 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 Open public recruiting
Date of protocol fixation
2020 Year 09 Month 07 Day
Date of IRB
2020 Year 09 Month 07 Day
Anticipated trial start date
2020 Year 09 Month 07 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Gene mutations of cfDNA in pancreatic juice or bile, progression of lesions in images, changes in serum tumor markers, gene mutations in surgical or biopsy specimens, clinical course

Management information
Registered date
2021 Year 04 Month 26 Day
Last modified on
2021 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050283

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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