UMIN-CTR Clinical Trial

Basic information
Public title	A phase II 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	A phase II study of the proportion of criteria for NCC Oncopanel for the specimen of unresectable pancreatic cancer obtained by EUS-FNB
Scientific Title	A phase II 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	A phase II 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 history of resection or reconstructive surgery of the esophagus, stomach, or duodenum 7)No massive ascites involving the liver 8)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 Kosuke Middle name Last name Maehara
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	kmaehara@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	33
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	No longer recruiting
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	2022 Year 03 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049131