UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031492 |
|---|---|
| Receipt number | R000035889 |
| Scientific Title | Verification test on pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin |
| Date of disclosure of the study information | 2018/02/27 |
| Last modified on | 2023/09/02 18:36:48 |
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Basic information
Public title
Verification test on pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin
Acronym
S-PJC
Scientific Title
Verification test on pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin
Scientific Title:Acronym
S-PJC
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify pancreatic cancer diagnosis by pancreatic juice cytology using synthetic secretin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
To examine the improvement of pancreatic cancer diagnostic ability by pancreatic juice cytology after secretin administration.
Key secondary outcomes
1) To verify pancreatic cancer diagnosis by exosome or cfDNA in pancreatic juice using synthetic secretin
2) To verify the pancreatic cancer diagnosis by MRI image using synthetic secretin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Administration of synthetic secretin
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
1. Patient provided informed consent at over 20 years old
2. Patients suspected of pancreatic cancer by image examination, or patients with IPMN which is classified as "high risk stigmata" or "worrisome features" by international consensus guidelines.
Key exclusion criteria
1) Patients with hypersensitivity to secretin or other ingredients (excipients: glycine hydrochloride, glycine, and polypeline).
2) Patients within 2 weeks after remission from acute pancreatitis or acute exacerbations of chronic pancreatitis.
3) A pregnant or lactating woman.
4) Patients who received other research drugs or investigational drugs within 3 months prior to the start
Target sample size
420
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Isomoto |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Gastroenterology and Nephrology, Department of Multidisciplinary Internal Medicine,
Zip code
683-8504
Address
36-1 Nishicho, Yonago, Japan.
TEL
0859-38-6527
isomoto@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Takeda |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Gastroenterology and Nephrology, Department of Multidisciplinary Internal Medicine,
Zip code
683-8504
Address
36-1 Nishicho, Yonago, Japan.
TEL
0859-38-6527
Homepage URL
yhytkd7@outlook.jp
Sponsor or person
Institute
Division of Gastroenterology and Nephrology, Department of Multidisciplinary Internal Medicine, Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
Medicine and Clinical Science, Faculty of Medicine, Tottori 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
Certified Review Board, Tottori University Hospital
Address
36-1 Nishicho, Yonago, Japan.
Tel
0859387021
cert.office@ml.med.tottori-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
鳥取大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Upcoming Listings
Publication of results
Unpublished
Result
URL related to results and publications
Upcoming Listings
Number of participants that the trial has enrolled
196
Results
under investigation
Results date posted
| 2023 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
under investigation
Participant flow
After obtaining consent, the patients will be enrolled in this study. After that, 0.5 microgram of ChiroStim will be administered intravenously, and MRCP will be performed. ERCP will be performed on a day other than the day of MRCP. Subsequently, 0.5 microgram of ChiroStim will be administered intravenously, and pancreatic juice will be collected after pancreatography by ERCP. After centrifugation of the pancreatic juice, the sediment will be smeared, and a cytology specimen will be prepared. Extracellular vesicles (EVs), including exosomes and functional RNAs (ncRNAs) such as LINC2280, HEVEPA, HULC, linc-RoR, HOTAIR, MALAT1, and other RNA groups, including ncRNAs, will be analyzed from supernatants not used for pathological diagnosis. Additionally, the presence and frequency of somatic mutations, such as KRAS, BRAF, CDKN2A, SMAD4, TP53, and GNAS, which are frequently found in pancreatic tumors, will be analyzed using next-generation sequencing (molecular barcoding) and digital PCR. The copy number (existence ratio) of somatic mutations will be detected and quantified by the Qubit fluorescence method and BioAnalyzer/TapeStation. If more than 2 mL of pancreatic juice can be collected at any time before or after synthetic secretin loading, 1 mL of undiluted pancreatic juice will be used for this study before centrifugation. The undiluted pancreatic juice will be assayed for ncRNAs, EVs, and cfDNA. Additionally, blood samples will be taken before and after synthetic secretin loading to analyze cfDNA, EVs, and ncRNAs.
Among these cfDNAs, CDKN2A, SMAD4, and TP53, which are classified as 59 genes recommended by the American College of Medical Genetics and Genomics (ACMG) as genes for secondary finding disclosure, will have the following measures taken in advance to ensure that KRAS, BRAF, and GNAS are excluded from the disclosure of secondary findings:
Variant allele frequency <30% for single nucleotide substitutions or <20% for insertions/deletions: Phenotypes should be evaluated based on medical and family history, and confirmatory tests in the germline should be offered if available. If there is no phenotype, it is not subject to disclosure.
(2) If the variant allele frequency is more than 30% for single nucleotide substitutions or more than 20% for insertions/deletions, and the TP53 gene is abnormal, the phenotype will be evaluated based on medical and family history, and a confirmatory test in the germline will be offered if found.
For secondary findings that are incidentally observed at this time, please refer to the "Research on the development of a system for appropriate disclosure of genomic information in the medical field Principal investigator: Shinji Kosugi, Kyoto University" of the Japan Agency for Medical and Biological Devices (AMED). The secondary findings that are incidentally found in this case will be handled in accordance with the report from "Shinji Kosugi, Kyoto University" of the Japan Agency for Medical and Health Care Research.
Adverse events
under investigation
Outcome measures
Primary endpoints
Diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value) of cytological diagnosis of pancreatic cancer using pancreatic juice after synthetic secretin administration.
Secondary endpoints
Diagnostic performance of pancreatic cancer by extracellular vesicles (EVs) including Exosomes and microvesicles, functional RNA and cfDNA in pancreatic juice or pancreatic juice supernatant and blood (sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value)
Diagnostic performance of pancreatic cancer by MRI images after synthetic secretin administration (sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 27 | Day |
Last modified on
| 2023 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035889
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