UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057117 |
|---|---|
| Receipt number | R000065278 |
| Scientific Title | Evaluation of Pancreatic Cancer Screening Accuracy Using C. elegans-Based Cancer Test (N-NOSE) and Tumor Markers |
| Date of disclosure of the study information | 2025/02/22 |
| Last modified on | 2025/02/22 14:59:19 |
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Basic information
Public title
Evaluation of Pancreatic Cancer Screening Accuracy Using C. elegans-Based Cancer Test (N-NOSE) and Tumor Markers
Acronym
Evaluation of Pancreatic Cancer Screening Accuracy Using C. elegans-Based Cancer Test (N-NOSE) and Tumor Markers
Scientific Title
Evaluation of Pancreatic Cancer Screening Accuracy Using C. elegans-Based Cancer Test (N-NOSE) and Tumor Markers
Scientific Title:Acronym
Evaluation of Pancreatic Cancer Screening Accuracy Using C. elegans-Based Cancer Test (N-NOSE) and Tumor Markers
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients diagnosed with pancreatic cancer will be included in the study group, while those diagnosed as non-pancreatic cancer will form the control group. Urine samples from both groups will be tested using N-NOSE, and blood samples will be analyzed for tumor markers and pancreatic enzymes. The discriminatory ability of the N-NOSE index and tumor marker values to distinguish cancer from non-cancer will be evaluated and compared by cancer stage and tumor location.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The discriminatory ability (ROC) of the N-NOSE index and tumor marker values in distinguishing cancer from non-cancer will be analyzed based on cancer stage and tumor location.
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
Patients hospitalized or receiving outpatient care at the Division of Gastroenterology, Showa University Hospital, diagnosed with pancreatic cancer, pancreatic mass, pancreatic cystic lesions, pancreatic duct dilation, or chronic pancreatitis.
Patients aged 20 years or older at the time of consent acquisition.
Patients who have provided written informed consent to participate in this study.
Key exclusion criteria
Patients with malignancies other than pancreatic cancer.
Patients with a history of cancer.
Patients deemed ineligible by the principal investigator based on clinical judgment.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Inoki |
Organization
Department of Medicine, Showa University School of Medicine
Division name
Division of Gastroenterology
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo 142-8666, Japan
TEL
0337848535
kinoki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Inoki |
Organization
Department of Medicine, Showa University School of Medicine
Division name
Division of Gastroenterology
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo 142-8666, Japan
TEL
0337848535
Homepage URL
kinoki@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa university
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
Showa University Research Administration Center
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo 142-8666, Japan
Tel
0337848129
m-rinri@ofc.showa-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 | 02 | Month | 22 | 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
160
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
| 2020 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | 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
Patients diagnosed with pancreatic mass, pancreatic duct dilation, pancreatic cystic lesions, or chronic pancreatitis based on abdominal ultrasound, CT, or MRI will be classified into two groups: those diagnosed with pancreatic cancer (study group) and those diagnosed as non-pancreatic cancer (control group). Urine samples from both groups will be analyzed using N-NOSE, while blood samples will be tested for tumor markers and pancreatic enzymes. The discriminatory ability of the N-NOSE index and tumor marker values in distinguishing cancer from non-cancer will be evaluated and compared by cancer stage and tumor location.
Management information
Registered date
| 2025 | Year | 02 | Month | 22 | Day |
Last modified on
| 2025 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065278
