UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057696 |
|---|---|
| Receipt number | R000065927 |
| Scientific Title | A follow-up study of patients with risk factors for pancreatic cancer using urinary biomarkers |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2025/08/19 15:43:51 |
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Basic information
Public title
A follow-up study of patients with risk factors for pancreatic cancer using urinary biomarkers
Acronym
A follow-up study of patients with risk factors for pancreatic cancer using urinary biomarkers
Scientific Title
A follow-up study of patients with risk factors for pancreatic cancer using urinary biomarkers
Scientific Title:Acronym
A follow-up study of patients with risk factors for pancreatic cancer using urinary biomarkers
Region
| Japan |
Condition
Condition
pancreatic cancer high-risk patients
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.We will analyze miRNA profiles obtained from comprehensive measurements of miRNAs extracted from urine samples of patients with risk factors for pancreatic cancer (high-risk patients for pancreatic cancer) and evaluate their relevance to clinical information obtained through routine medical care. In particular, if the development of pancreatic cancer is confirmed during the follow-up period, we will analyze the changes in miRNA profiles leading up to the development of pancreatic cancer
2.We will comprehensively analyze the methylation patterns of cfDNA extracted from urine samples of high-risk pancreatic cancer patients and evaluate the relevance of the methylation patterns to clinical information obtained through routine medical care. In particular, if the development of pancreatic cancer is confirmed during the follow-up period, we will analyze the changes in miRNA profiles leading up to the development of pancreatic cancer.
Basic objectives2
Others
Basic objectives -Others
We will measure and analyze other biomarkers (nucleic acids, proteins, metabolites, urine qualitative, etc.) extracted from urine samples of patients at high risk of pancreatic cancer, and evaluate their relevance to the clinical information obtained in the usual medical examination. By complementing the previous analysis of miRNA profiles and cfDNA methylation patterns, we will search for urinary biomarkers to more accurately capture pathological changes (e.g., development of pancreatic cancer) in patients at high risk for pancreatic cancer.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We will measure miRNA profiles and DNA methylation profiles from the specimens collected in this study. The correlation between these profiles and clinical information, such as changes in the condition of high-risk pancreatic cancer patients (including the onset of pancreatic cancer), will be evaluated over the follow-up period.
In especially cases where the development of pancreatic cancer is confirmed during the follow-up period, changes in miRNA profiles leading up to the development of pancreatic cancer will be analyzed.
Key secondary outcomes
Additionally, we will apply the classification model for pancreatic cancer diagnosis, including early stages, which was constructed using machine learning of miRNA profiles in previous joint research by Craif Inc. We will evaluate the correlation between the judgment results of this classification model and clinical information.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese who are 40 years of age or older on the date of signing the consent form.
2) Persons who are able to obtain written consent for participation in this study of their own free will from the Institute, using a consent document approved by the Ethical Review Committee, etc. of each research institution.
3) Those who have one or more of the following high-risk factors for pancreatic cancer. (1) Patients who have been treated for any of the following diseases or co-morbidities.
Type 2 diabetes, chronic pancreatitis, family history of pancreatic cancer (at least one parent, child, or sibling who is a first-degree relative has a history of pancreatic cancer), IPMN, pancreatic cyst, pancreatic duct dilation
4) Those who can expect regular visits to the hospital (at least once every 6 months) for at least the next 1 year.
Key exclusion criteria
1) Patients who have difficulty urinating on their own due to severe renal failure or need nursing care to urinate.
2) Women who are currently pregnant, may become pregnant, or plan to become pregnant within the next year.
3)Currently diagnosed with a malignancy or have a history of malignancy within the past 5 years.
4)Are currently participating in an interventional trial (including clinical trials) other than this study or plan to participate in an interventional trial (including clinical trials) in the next 1 year.
5) Any other person who is deemed inappropriate by the investigator of the research institution.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ichikawa |
Organization
Craif Inc.
Division name
CTO
Zip code
162-0814
Address
B1F THE PORTAL iidabashi, 8-30 Shin-ogawamachi, Shinjuku-ku, Tokyo 162-0814, 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 and Regulatory Affiars
Zip code
162-0814
Address
B1F THE PORTAL iidabashi, 8-30 Shin-ogawamachi, Shinjuku-ku, Tokyo 162-0814, Japan
TEL
03-6801-8334
Homepage URL
clinicaltrial@craif.com
Sponsor or person
Institute
Craif Inc.
Institute
Department
Personal name
Funding Source
Organization
Craif 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
Craif Inc.
Address
B1F THE PORTAL iidabashi, 8-30 Shin-ogawamachi, Shinjuku-ku, Tokyo 162-0814, 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
| 2025 | Year | 04 | Month | 23 | 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
| 2025 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065927
