UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049929 |
|---|---|
| Receipt number | R000056869 |
| Scientific Title | Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers: Validation test of sample measured value for each storage method |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 10:20:36 |
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Basic information
Public title
Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers: Validation test of sample measured value for each storage method
Acronym
Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers: Validation test of sample measured value for each storage method
Scientific Title
Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers: Validation test of sample measured value for each storage method
Scientific Title:Acronym
Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers: Validation test of sample measured value for each storage method
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to assess the utility of S100 protein levels in the duodenal juice collected by oral endoscopy without pancreatic duct cannulation to detect pancreatic cancers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The S100 protein concentration in the duodenal juice to detect patients with pancreatic cancers
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pancreatic cancer patients
1) Aged 50 or more
2) Patients who undergo preoperative screening upper gastrointestinal endoscopy or endoscopic ultrasonography (EUS) for the assessment of pancreatic cancer
3) Written informed consent
4) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer
5) Patients who have undergone no surgery in gastrointestinal lesion
6) Patients without malignant disease in bile duct
The patients who undergo physical examination
1) Aged 50 or more.
2) Patients proven to have normal pancreas by EUS
3) Patients who undergo screening upper gastrointestinal endoscopy for their pancreatic diseases
4) Written informed consent
5) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer
6) Patients who have undergone no surgery in gastrointestinal lesion, such as gastrectomy, pancreatoduodenectomy and so on.
7) Patients without malignant disease in bile duct
Key exclusion criteria
1) They have no drug hypersensitivity.
2) The doctor-in-charge figures them to be suitable for this study.
Target sample size
117
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nakamura |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL
092-631-2920
nakamura.masafumi.861@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Ideno |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL
092-631-2920
Homepage URL
ideno.noboru.033@m.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Kyushu University
Address
3-1-1-WW610, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
| 2022 | Year | 12 | Month | 28 | 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
117
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 | 12 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the "Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers" in 2020, it was observed that S100P values differed significantly depending on the preservation method of duodenal fluid. In particular, some samples from healthy subjects were below the detection limit by storage method D (conventional storage method in which protease inhibitor is directly dissolved in duodenal fluid), but were high by storage method A (new storage method in which duodenal fluid is added to sample dilution solution). In order to confirm the cause of this difference in measured values and the validity of the measured values, we will analyze the duodenal fluid samples with significantly different measured values using three methods: (1) inhibition test, (2) dilution linearity test, and (3) additive recovery test. Since the number of specimens used in each analysis depends on the remaining specimen volume, the same specimens may not be analyzed by all three methods.
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056869
