UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048966 |
|---|---|
| Receipt number | R000055788 |
| Scientific Title | The Success of OncoGuide NCC OncoPanel System Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-guided Tissue Acquisition Using TopGain 19G from Primary and Metastatic Lesions in Pancreatic Cancer with Metastatic Lesions: A Prospective Self-Controlled Study |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/03/25 13:25:24 |
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Basic information
Public title
A study to determine the optimal puncture site for endoscopic ultrasound-guided tissue sampling in anticipation of comprehensive genomic profiling for patients suspected of having pancreatic cancer.
Acronym
PRIMATE study
Scientific Title
The Success of OncoGuide NCC OncoPanel System Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-guided Tissue Acquisition Using TopGain 19G from Primary and Metastatic Lesions in Pancreatic Cancer with Metastatic Lesions: A Prospective Self-Controlled Study
Scientific Title:Acronym
PRIMATE study
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine whether primary or metastatic lesion is the optimal target for endoscopic ultrasound-guided tissue acquisition in pancreatic cancer with metastases, considering of comprehensive genomic profiling test in mind.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of the NCC OncoPanel criteria for analysis in precheck of specimens obtained by endoscopic ultrasound-guided tissue acquisition from primary pancreatic lesion
Success rate of the NCC OncoPanel criteria for analysis in precheck of specimens obtained by endoscopic ultrasound-guided tissue acquisition from metastatic lesions of pancreatic cancer
Key secondary outcomes
Success rate of the NCC OncoPanel criteria for analysis in precheck of specimens obtained by endoscopic ultrasound-guided tissue acquisition from primary pancreatic lesion and/or metastatic lesions
Technical success rate of endoscopic ultrasound-guided tissue acquisition with 19-gauge needle
The rate of adverse events
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
endoscopic ultrasound-guided tissue acquisition using TopGain 19-Gauge needle
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
Suspected pancreatic cancer with metastasis on CT, EUS, AUS, or MRI.
Safe to perform endoscopic ultrasound-guided tissue acqusition
Key exclusion criteria
Two or more lesions in the pancreas that are suspicious for pancreatic cancer
Target sample size
61
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Okusaka |
Organization
National cancer center hospital
Division name
Hepatobiliary and pancreatic oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National cancer center hospital
Division name
Hepatobiliary and pancreatic oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
shijioka@ncc.go.jp
Sponsor or person
Institute
National cancer center hospital
Institute
Department
Personal name
Funding Source
Organization
National cancer center hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
ktakeshi@ncc.go.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 | 10 | Month | 01 | 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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055788
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