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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043038
Receipt No. R000049131
Scientific Title Observational study of the proportion of criteria for The OncoGuide NCC Oncopanel System for the specimen of unresectable pancreatic cancer obtained by TopGain for EUS-guided fine-needle biopsy
Date of disclosure of the study information 2021/01/20
Last modified on 2021/02/02

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Basic information
Public title Observational study of the proportion of criteria for The OncoGuide NCC Oncopanel System for the specimen of unresectable pancreatic cancer obtained by TopGain for EUS-guided fine-needle biopsy
Acronym Observational study of the proportion of criteria for NCC Oncopanel for the specimen of unresectable pancreatic cancer obtained by EUS-FNB
Scientific Title Observational study of the proportion of criteria for The OncoGuide NCC Oncopanel System for the specimen of unresectable pancreatic cancer obtained by TopGain for EUS-guided fine-needle biopsy
Scientific Title:Acronym Observational study of the proportion of criteria for NCC Oncopanel for the specimen of unresectable pancreatic cancer obtained by EUS-FNB
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To elucidate the proportion of criteria for The OncoGuide NCC Oncopanel System for the specimen of unresectable pancreatic cancer obtained by TopGain for EUS-guided fine-needle biopsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of criteria for the NCC Oncopanel for the specimen obtained by EUS-guided fine-needle biopsy
Key secondary outcomes 1)Tumor cellularity and tissue area
2)The proportion of criteria for the FoundationOne
3)Tumor cellularity and tissue area by the nCounter system
4)The true proportion of criteria for the NCC Oncopanel and FoundationOne
5)Accuracy, sensitivity, specificity, technical success rate and complication rate (bleeding and pancreatitis)
6)A comparison of the proportion of criteria for the NCC Oncopanel between primary and metastatic lesion
7)Type of genetic mutation
8)The proportion of patients who actually received gene therapy
9)A comparison of OS and PFS between patients who actually received gene therapy and not received

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 EUS-FNB using TopGain
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)Unresectable pancreatic cancer and Invasive pancreatic ductal cancer depicted by contrast-enhanced computed tomography
2)ECOG performance status =0, 1, 2
3)Has not received chemotherapy for pancreatic cancer
4)No intervening blood vessels or other tumors between the lumen of the digestive tract and the target lesion
5)No bleeding tendency
6)No gastrointestinal stenosis
7)No history of resection or reconstructive surgery of the esophagus, stomach, or duodenum
8)No massive ascites involving the liver
9)The patient's written consent to participate in the study has been obtained
Key exclusion criteria 1)The physician determines that the patient's enrollment in the study is inappropriate
Target sample size 33

Research contact person
Name of lead principal investigator
1st name Susumu
Middle name
Last name Hijioka
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email shijoka@ncc.go.jp

Public contact
Name of contact person
1st name Yuya
Middle name
Last name Hisada
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email yuhisada@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
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 National Cancer Center Hospital
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel 03-3542-2511
Email shijoka@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
2021 Year 01 Month 20 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 Enrolling by invitation
Date of protocol fixation
2021 Year 01 Month 21 Day
Date of IRB
2021 Year 01 Month 28 Day
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 01 Month 18 Day
Last modified on
2021 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049131

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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