UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049412 |
|---|---|
| Receipt number | R000056213 |
| Scientific Title | Validation study of cancer detection system by circulating microRNA |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2023/05/03 09:57:00 |
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Basic information
Public title
Validation study of cancer detection system by circulating microRNA
Acronym
Validation study of cancer detection system by circulating microRNA
Scientific Title
Validation study of cancer detection system by circulating microRNA
Scientific Title:Acronym
Validation study of cancer detection system by circulating microRNA
Region
| Japan |
Condition
Condition
Pancreatic cancer, biliary tract cancer, healthy control
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validation of cancer detection system by circulating microRNA
Basic objectives2
Others
Basic objectives -Others
Validation of circulation microRNA detection system
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in the logarithmic detection amount of each microRNA between the pancreatic/biliary cancer group and the healthy adult group.
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
Pancreatic/biliary cancer patient
Patients diagnosed with pathologically (cytological/histological) or suspicious on the image asinvasive pancreatic duct cancer, gallbladder cancer, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or papillary carcinoma
Patients who can collect blood within 1 monthafter registration
Patients who have never undergone surgery or chemotherapy
Age 20+
No active malignant disease except pancreatic/biliary tract cancer
Healthy control
No history or complication of malignant disease, including carcinoma in situ or intramucosalcarcinoma
No history of hospitalization within the past 3months
Age 50+
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Sudo |
Organization
Toray Industries, Inc.
Division name
New Frontiers Research Laboratories
Zip code
248-8555
Address
6-10-1, Tebiro, Kamakura, Kanagawa
TEL
0467-32-9740
Hiroko.sudo.u8@mail.toray
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Takizawa |
Organization
Toray Industries, Inc.
Division name
New Projects Development Division
Zip code
248-8555
Address
6-10-1, Tebiro, Kamakura, Kanagawa
TEL
0467-32-9740
Homepage URL
satoko.takizawa.f3@mail.toray
Sponsor or person
Institute
Toray Industries, Inc.
Institute
Department
Personal name
Funding Source
Organization
Toray Industries, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Tissue Samples Ethics Committee forR&D Toray Ind., Inc.
Address
1-1-1, Sonoyama Otsu, Shiga, 520-8558
Tel
077-533-8188
hisashi.hashimoto.v8@mail.toray
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
| 2023 | Year | 01 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Case-control study
Objects: Patients who visited a partner institution in October 2022 and met the selection criteria and gave IC
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056213
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
