UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038639 |
|---|---|
| Receipt number | R000043784 |
| Scientific Title | Usefulness and safety of gene analysis for pancreatic tumor using endoscopic ultrasound-guided fine needle aspiration |
| Date of disclosure of the study information | 2019/11/19 |
| Last modified on | 2019/11/19 20:13:36 |
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Basic information
Public title
Usefulness and safety of gene analysis for pancreatic tumor using endoscopic ultrasound-guided fine needle aspiration
Acronym
Usefulness and safety of gene analysis for pancreatic tumor using endoscopic ultrasound-guided fine needle aspiration
Scientific Title
Usefulness and safety of gene analysis for pancreatic tumor using endoscopic ultrasound-guided fine needle aspiration
Scientific Title:Acronym
Usefulness and safety of gene analysis for pancreatic tumor using endoscopic ultrasound-guided fine needle aspiration
Region
| Japan |
Condition
Condition
Pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Nucleic acid extraction and NGS using pathological specimens by EUS-FNA are performed, and the expression and mutation of genes predicted to be related to tumors are analyzed to clarify their usefulness and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Detection of genetic mutations using nucleic acid extraction sequencing in tumor tissue and serum
Key secondary outcomes
Clinicopathological items
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Pancreatic tumor patients with malignant risks and treatment indications
2.Adult patients over 18 years old
3.Both inpatient and outpatient
4.Cases where the specimen collection time is after January 1, 2018
Key exclusion criteria
1.Collected specimen does not contain tumor cells
2.The doctor determined that it was inappropriate for this study
3.Concomitant with other cancer
4.Pregnancy or may be pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Iwaya |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Digestive and Lifestyle Diseases
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
hiro9011@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Iwaya |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Digestive and Lifestyle Diseases
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
0992755326
Homepage URL
hiro9011@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
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
Kagoshima University Graduate School of Medical and Dental Sciences
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
0992755326
hiro9011@m3.kufm.kagoshima-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
| 2019 | Year | 11 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to clarify whether pathological specimens obtained by endoscopic ultrasound-guided fine needle aspiration can keep sufficient quality and accuracy in gene analysis for pancreatic tumors.
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043784
