UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042498 |
|---|---|
| Receipt number | R000048387 |
| Scientific Title | A new finding on CT, K-sign, to detect the early-stage pancreatic cancer |
| Date of disclosure of the study information | 2020/11/19 |
| Last modified on | 2024/05/23 14:44:12 |
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Basic information
Public title
A new finding on CT, K-sign, to detect the early-stage pancreatic cancer
Acronym
A new finding on CT, K-sign, to detect the early-stage pancreatic cancer
Scientific Title
A new finding on CT, K-sign, to detect the early-stage pancreatic cancer
Scientific Title:Acronym
A new finding on CT, K-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 | Yutaka |
| Middle name | |
| Last name | Takigawa |
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
ytakigawa@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Takigawa |
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
ytakigawa@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College Ichikawa General Hospital
Institute
Department
Personal name
Yutaka Takigawa
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
mishii@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 2026 in our facility. We prospectively examine pancreatic morphological abnormalities with "K-shaped sign" and the development of pancreatic cancer. The registration period and the observation period are the same as above. 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
| 2024 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048387
