UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030757
Receipt No. R000035123
Scientific Title Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA
Date of disclosure of the study information 2018/01/20
Last modified on 2019/07/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA
Acronym Comprehensive gene analysis for the specimen of pancreatic cancer
Scientific Title Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA
Scientific Title:Acronym Comprehensive gene analysis for the specimen of pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the acquision rate of the specimen of pancreatic cancer obtained by EUS-FNA for comprehensive gene analysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Acquision rate of the specimen obtained by EUS-FNA for comprehensive gene analysis.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 The specimen of pancreatic cancer obtained by EUS-FNA of the first pass is used for this study.
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. More than 20 years old
2. Hypovascular pancreatic tumor
3. Necessary of EUS-FNA for diagnosis
4. Performance status with more than 2
5. Without severe complication
6. Acquisition of patients agreement
Key exclusion criteria 1. Presence of interveneous vesseles in the puncture line during EUS-FNA
2. High risk of bleeding
3. Difficulty of performing EUS
4. Without informed consent
5. Deemed ineligible
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Mamoru
Middle name
Last name Takenaka
Organization Kindai University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL 072-366-0221
Email mamoxyo45@gmail.com

Public contact
Name of contact person
1st name Ken
Middle name
Last name Kamata
Organization Kindai University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 589-8511
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email ky11@leto.eonet.ne.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization Kindai University
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 Kindai Univercity faculty of medicine
Address Osaka
Tel 0722201181
Email ky11@leto.eonet.ne.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
2018 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 18 Day
Date of IRB
2018 Year 01 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 10 Day
Last modified on
2019 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.