UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040099 |
|---|---|
| Receipt number | R000045720 |
| Scientific Title | Diagnostic quality of Endoscopic Ultrasound-guided Fine Needle Aspiration for Onco-panel for Geneprofiling of pancreatic cancer - Prospective cohort study - |
| Date of disclosure of the study information | 2020/04/10 |
| Last modified on | 2020/04/07 20:37:46 |
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Basic information
Public title
Diagnostic quality of Endoscopic Ultrasound-guided Fine Needle Aspiration for Onco-panel for Geneprofiling of pancreatic cancer - Prospective cohort study -
Acronym
EUS-FNA for Onco-panel for Geneprofiling
Scientific Title
Diagnostic quality of Endoscopic Ultrasound-guided Fine Needle Aspiration for Onco-panel for Geneprofiling of pancreatic cancer - Prospective cohort study -
Scientific Title:Acronym
EUS-FNA for Onco-panel for Geneprofiling
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify how Onco-panel for Geneprofiling can be evaluated by specimens of EUS-FNA for pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic sensitivity of Onco-panel for Geneprofiling by specimens of EUS-FNA for pancreatic cancer
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 with unresectable pancreatic cancer diagnosed by imaging and clinically judged to be eligible for Onco-panel for Geneprofiling during the course of chemotherapy
Key exclusion criteria
# Patients who have tendency of bleeding
# The lesion cannot be demonstrated
# Patients who have the high risk of complication by EUS-FNA
# There are some definite vessels between EUS and lesions
# The movement by breathing may cause puncture of another organs
# Patients who don't understand the aim of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yasuda |
Organization
University of Toyama
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL
076-434-7301
yasudaich@gmail.com
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Takahashi |
Organization
University of Toyama
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama prefecture, Japan
TEL
076-434-7301
Homepage URL
takapochi0809@gmail.com
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
None
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
Center for Clinical Reserch in Toyama University Hospital
Address
2630 Sugitani, Toyama city, Toyama prefecture, Japan
Tel
076-415-8857
rinri@adm.u-toyama.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
| 2020 | Year | 04 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate diagnostic sensitivity of Onco-panel for Geneprofiling by EUS-FNA for pancreatic cancer.
Management information
Registered date
| 2020 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045720
