UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044562 |
|---|---|
| Receipt number | R000050904 |
| Scientific Title | Clinical pathological gene research for the pathophysiology and diagnostic accuracy of pancreatic tumors |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2023/12/18 16:04:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical pathological gene research for the pathophysiology and diagnostic accuracy of pancreatic tumors
Acronym
Genetic research of pancreatic tumors
Scientific Title
Clinical pathological gene research for the pathophysiology and diagnostic accuracy of pancreatic tumors
Scientific Title:Acronym
Genetic research of pancreatic tumors
Region
| Japan |
Condition
Condition
Pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate of the mechanism of malignant transformation of pancreatic cancer and IPMN, this study analyzes the relationship between gene mutation and clinical factors of pancreatic cancer, its precancerous lesions and pancreatic tumors including Pan-IN and IPMN.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive rate of genetic markers that relate prognosis.
Key secondary outcomes
To identify clinical factors that relate prognosis.
Overall gene mutation rate and molecular marker expression rate.
Expression rate of gene mutations and molecular markers associated with each clinical factors.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pancreatic cancer patients.
Patients who underwent surgery or detailed examination for pancreatic tumor.
Control patients.
Key exclusion criteria
not applicable
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Takano |
Organization
University of Yamanashi
Division name
Division of gastroenterology and hepatology
Zip code
409-3898
Address
1110 Shomokato Chuo Yamanashi Japan
TEL
055-273-9584
stakano@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Takano |
Organization
University of Yamanashi
Division name
Division of gastroenterology and hepatology
Zip code
409-3898
Address
1110 Shomokato Chuo Yamanashi Japan
TEL
055-273-9584
Homepage URL
stakano@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Division of gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
University of Yamanashi
Address
1110 Shomokato Chuo Yamanashi Japan
Tel
055-273-9065
stakano@yamanashi.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
| 2021 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1111/cas.15249
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/cas.15249
Number of participants that the trial has enrolled
172
Results
The most common genetic abnormalities obtained were KRAS (82%), TP53 (57%), SMAD4 (19%), and RET (16%). Genetic abnormalities that could be markers for FDA-approved molecular-targeted drugs were found in 30 patients (20%) in 93 locations, and 14% of patients had abnormalities in genes related to homologous recombination repair, a potential marker for FOLFIRINOX, which is used in clinical practice.
Results date posted
| 2023 | Year | 12 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 161 patients (Stage I/II/III/IV=6/72/22/61) who underwent EUS-FNA for pancreatic cancer were included.
Participant flow
Patients who were able to give written consent for the study at the time of patient consultation were included in the study.
Adverse events
Nothing particular.
Outcome measures
Genetic abnormalities of biopsied samples.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we obtained 185 tissue samples from 172 patients with pancreatic cancer who underwent EUS-FNA or endoscopic biopsy of an invading tumor at the Yamanashi University hospital between July 2014 and December 2019. We then performed next-generation sequencing analysis on endoscopically-obtained FFPE samples from patients with pancreatic cancer to identify therapeutic targets and determine the clinical significance of these targets through comparisons with the clinical information of the patients.
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050904
