UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058066 |
|---|---|
| Receipt number | R000066323 |
| Scientific Title | A Study on Plasma Markers for Early Detection of Pancreatic Cancer |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/03 12:58:00 |
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Basic information
Public title
A Study on Plasma Markers for Early Detection of Pancreatic Cancer
Acronym
A Study on Plasma Markers for Early Detection of Pancreatic Cancer
Scientific Title
A Study on Plasma Markers for Early Detection of Pancreatic Cancer
Scientific Title:Acronym
A Study on Plasma Markers for Early Detection of Pancreatic Cancer
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the usefulness of plasma SPINK1 levels for the early detection of pancreatic cancer and to calculate the sensitivity and specificity of plasma SPINK1 concentration with an appropriate threshold value.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The utility of plasma SPINK1 concentration in predicting the presence of pancreatic cancer
Key secondary outcomes
1. The sensitivity and specificity of plasma SPINK1 levels for predicting pancreatic cancer, along with an appropriate threshold setting
2. The association between Plasma SPINK1 levels and patient background factors (age, gender, BMI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blood collection: Approximately 2 ml of blood is collected in healthy control case.
Interventions/Control_2
Blood collection: Approximately 2 ml of blood is collected in pancreatic cancer case.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy Control Cases
Cases that meet all of the following criteria:
- Age between 40 and 85 years inclusive
- Written informed consent obtained from the individual for participation in this study
Pancreatic Cancer Cases
Cases that meet all of the following criteria:
- Age between 40 and 85 years inclusive
- Written informed consent obtained from the individual for participation in this study
- Registered in the separate trial titled "Investigation of Hypoxic Regions and the Effectiveness of Radiotherapy in Pancreatic Cancer (C1491-1)"
Key exclusion criteria
Cases that meet any of the following criteria will be excluded from this study:
- History of malignant tumors
- Cases deemed inappropriate by the principal investigator or co-investigators due to medical or other factors (e.g., poor general condition)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Harada |
Organization
Kyoto University
Division name
Radiation Biology Center, Graduate School of Biostudies
Zip code
606-8501
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto City, Kyoto, Japan
TEL
075-753-7560
harada.hiroshi.5e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Suwa |
Organization
Kyoto University Hospital
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
606-8507
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto City, Kyoto, Japan
TEL
075-751-3762
Homepage URL
tsuwa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-u.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
| 2025 | Year | 06 | Month | 30 | 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
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066323
