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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031492
Receipt No. R000035889
Scientific Title Verification test on pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin
Date of disclosure of the study information 2018/02/27
Last modified on 2019/03/04

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Basic information
Public title Verification test on pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin
Acronym S-PJC
Scientific Title Verification test on pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin
Scientific Title:Acronym S-PJC
Region
Japan

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

Objectives
Narrative objectives1 To verify pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes To examine the improvement of pancreatic cancer diagnostic ability by pancreatic juice cytology after secretin administration.
Key secondary outcomes 1) To verify pancreatic cancer diagnosis by exosome or cfDNA in pancreatic juice using synthetic secretin
2) To verify the pancreatic cancer diagnosis by MRI image using synthetic secretin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Administration of synthetic secretin
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. Patient provided informed consent at over 20 years old
2. Patients suspected of pancreatic cancer by image examination, or patients with IPMN which is classified as "high risk stigmata" or "worrisome features" by international consensus guidelines.
Key exclusion criteria 1) Patients with hypersensitivity to secretin or other ingredients (excipients: glycine hydrochloride, glycine, and polypeline).
2) Patients within 2 weeks after remission from acute pancreatitis or acute exacerbations of chronic pancreatitis.
3) A pregnant or lactating woman.
4) Patients who received other research drugs or investigational drugs within 3 months prior to the start
Target sample size 420

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Isomoto
Organization Faculty of Medicine, Tottori University
Division name Medicine and Clinical Science
Zip code
Address 36-1 Nishicho, Yonago, Japan.
TEL 0859-38-6527
Email isomoto@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Takeda
Organization Faculty of Medicine, Tottori University
Division name Medicine and Clinical Science
Zip code
Address 36-1 Nishicho, Yonago, Japan.
TEL 0859-38-6527
Homepage URL
Email yhytkd7@outlook.jp

Sponsor
Institute Medicine and Clinical Science, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Medicine and Clinical Science, Faculty of Medicine, Tottori University
Organization
Division
Category of Funding Organization Other
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 鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 27 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 Enrolling by invitation
Date of protocol fixation
2011 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 02 Month 28 Day
Date analysis concluded
2018 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035889

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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