UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053882 |
|---|---|
| Receipt number | R000061507 |
| Scientific Title | Clinical Study of Pancreatic Cancer Diagnostic Performance Using Machine Learning Model with Urinary Biomarkers |
| Date of disclosure of the study information | 2024/03/18 |
| Last modified on | 2024/04/30 09:17:22 |
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Basic information
Public title
Clinical Study of Pancreatic Cancer Diagnostic Performance Using Machine Learning Model with Urinary Biomarkers
Acronym
Clinical Study of Pancreatic Cancer Diagnostic Performance Using Machine Learning Model with Urinary Biomarkers
Scientific Title
Clinical Study of Pancreatic Cancer Diagnostic Performance Using Machine Learning Model with Urinary Biomarkers
Scientific Title:Acronym
Clinical Study of Pancreatic Cancer Diagnostic Performance Using Machine Learning Model with Urinary Biomarkers
Region
| Japan |
Condition
Condition
Pancreatic cancer, pancreatic cancer high-risk patients
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1. Performance evaluation of a pancreatic cancer prediction model based on miRNA profiles
We will evaluate the diagnostic performance of our prediction model for pancreatic cancer based on miRNA profiles obtained from comprehensive measurements of miRNAs extracted from urine samples of pancreatic cancer patients, non-pancreatic cancer (high-risk pancreatic cancer) patients and healthy adults, and clinical information obtained during routine medical care.
2. Evaluation of the performance of the prediction model for pancreatic cancer based on DNA methylation patterns
We will evaluate the diagnostic performance of the predictive model for pancreatic cancer based on DNA methylation patterns obtained from comprehensive measurement of cfDNA extracted from urine samples of pancreatic cancer patients, non-pancreatic cancer (high-risk pancreatic cancer) patients, and healthy adults, as well as clinical information obtained in the usual medical practice.
Basic objectives2
Others
Basic objectives -Others
Exploratory analysis of other biomarkers in urine
We will measure and analyze other biomarkers (nucleic acids, proteins, metabolites, urine qualitative analysis, etc.) extracted from urine samples of pancreatic cancer patients, non-pancreatic cancer (high-risk pancreatic cancer) patients, and healthy adults, and by correlating them with clinical information obtained during routine medical care, we will improve the risk prediction performance of miSignal for pancreatic cancer, and develop new biomarkers combining them.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Using the predictive model or biomarker constructed to classify pancreatic cancer and non-pancreatic cancer (pancreatic cancer high-risk) groups, the following will be evaluated.
(1) Sensitivity, specificity, positive predictive value, negative predictive value, and positive diagnostic value for pancreatic cancer
(2) Sensitivity to pancreatic cancer by stage
(3) Sensitivity to pancreatic cancer by tumor size
(4) Comparison with sensitivity, specificity, positive predictive value, negative predictive value, and positive diagnostic value of each test item (including imaging tests) in the participants of this study
(5) Comparison with the sensitivity and specificity of each test item (including imaging tests) in previous reports
(6) Sensitivity, specificity, and positive predictive value for pancreatic cancer in multiple prediction models
(7) Sensitivity, specificity, and positive diagnostic rate for pancreatic cancer in each of the other subpopulations
(8) Sensitivity, specificity, and positive diagnostic rate for pancreatic cancer when combined with other test items
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pancreatic Cancer Patients:
To qualify for this study, individuals must meet criteria (1) through (5):
(1) Japanese nationals aged 18 years or older at the time of signing the consent form.
(2) Written consent, approved by the Ethical Review Committee of the respective research institution, can be obtained from the individual or their surrogate, based on their free will.
(3) Diagnosis of invasive pancreatic ductal carcinoma (PDAC) or suspected intraductal papillary mucinous carcinoma (IPMC) with scheduled surgery.
(4) Blood samples collected within the past 90 days used to measure CA19-9.
(5) No prior treatment for invasive PDAC or suspected IPMC at the time of consent.
Non-Pancreatic Cancer (Pancreatic Cancer High-Risk) Patients:
To be eligible for this study, individuals must meet criteria (1) through (4):
(1) Japanese nationals aged 18 years or older at the time of signing the consent form.
(2) Written consent, based on their or their surrogate's free will, using an approved consent document from the Ethical Review Committee of the respective research institution.
(3) Imaging studies ruling out pancreatic cancer or pathology confirming the absence of pancreatic cancer.
(4) Presence of high-risk factors for pancreatic cancer: type 2 diabetes mellitus, chronic pancreatitis, family history of pancreatic cancer, intraductal papillary mucinous neoplasm (IPMN), pancreatic cyst, or pancreatic duct dilation.
Healthy Volunteers:
To participate in this study, individuals must meet criteria (1) through (3):
(1) Japanese nationals aged 50 years or older at the time of signing the consent form.
(2) Able to provide written consent willingly using an approved consent document from the Ethical Review Committee of the respective research institution.
(3) Assessed by a physician to be in good health based on medical evaluation, including history, physical examination, vital signs, and laboratory values.
Key exclusion criteria
Patients who meet any of the following criteria (1) through (6) will not be included in this study.
(1) Patients who have difficulty urinating on their own due to severe renal failure, need nursing care for urination, etc.
(2) Patients who are pregnant or may become pregnant.
(3) Women who are menstruating at the time of scheduled urine sample collection.
(4) Patients with a history of malignancy in the past.
(5) Those who are currently participating in an interventional study (including clinical trials) other than this study.
(6) Any other person who is deemed inappropriate by the investigator.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ichikawa |
Organization
Craif Inc.
Division name
Chief Technology Officer
Zip code
113-0034
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
clinicaltrial@craif.com
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Mikami |
Organization
Craif inc.
Division name
Clinical Development
Zip code
113-0034
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
TEL
03-6801-8334
Homepage URL
clinicaltrial@craif.com
Sponsor or person
Institute
Craif Inc.
Institute
Department
Personal name
Funding Source
Organization
Self funded
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Craif Institutional Review Board
Address
5F ITP Hongo Office , 2-25-7 Yushima, Bunkyo-ku, Tokyo, 113-0034, Japan
Tel
03-6801-8334
clinicaltrial@craif.com
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
| 2024 | Year | 03 | Month | 18 | 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
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061507
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