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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042498
Receipt No. R000048387
Scientific Title A new finding on CT, K-Shaped Sign, to detect the early-stage pancreatic cancer
Date of disclosure of the study information 2020/11/19
Last modified on 2020/11/19

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Basic information
Public title A new finding on CT, K-Shaped Sign, to detect the early-stage pancreatic cancer
Acronym A new finding on CT, K-Shaped Sign, to detect the early-stage pancreatic cancer
Scientific Title A new finding on CT, K-Shaped Sign, to detect the early-stage pancreatic cancer
Scientific Title:Acronym A new finding on CT, K-Shaped Sign, to detect the early-stage pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 To detect early-stage pancreatic cancer and improve the prognosis by prospectively examining and tracking the patients with K-shaped sign on CT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Positive predictive value for early diagnosis of pancreatic cancer with K-shaped sign.
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 Patients with pancreatic morphological abnormalities such as K-shaped sign on CT
Key exclusion criteria Patients with a history of hepatobiliary pancreatic scrutiny and surgery
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Matsui
Organization Tokyo Dental College Ichikawa General Hospital
Division name Surgery
Zip code 272-8513
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL +81-47-322-0151
Email matsuij@tdc.ac.jp

Public contact
Name of contact person
1st name Junichi
Middle name
Last name Matsui
Organization Tokyo Dental College Ichikawa General Hospital
Division name Surgery
Zip code 272-8513
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL +81473220151
Homepage URL
Email matsuij@tdc.ac.jp

Sponsor
Institute Tokyo Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization Tokyo Dental College Ichikawa General Hospital
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 Tokyo Dental College Ichikawa General Hospital
Address 5-11-13, Sugano, Ichikawa, Chiba, Japan
Tel +81473220151
Email matsuij@tdc.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
2020 Year 11 Month 19 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
2019 Year 04 Month 16 Day
Date of IRB
2019 Year 04 Month 16 Day
Anticipated trial start date
2019 Year 04 Month 16 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study design is a prospective observational study. The method of recruitment is for patients who had pancreatic morphological abnormalities such as "K-shaped sign" on CT from April 2019 to March 2021 in our facility. We prospectively examine pancreatic morphological abnormalities with "K-shaped sign" and the development of pancreatic cancer. The registration period is two years and the observation period is five years. The entire research period is from the day of the approval of the research by the Ethics Committee to 31 March 2026.

Management information
Registered date
2020 Year 11 Month 19 Day
Last modified on
2020 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048387

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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