UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043038 |
|---|---|
| Receipt number | R000049131 |
| 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 |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2022/03/18 13:33:07 |
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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
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
kmaehara@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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049131
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