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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020831
Receipt No. R000024047
Scientific Title A prospective study of endoscopic diagnosis through the submucosal tunnel for gastrointestinal submucosal tumors
Date of disclosure of the study information 2016/02/03
Last modified on 2017/08/03

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Basic information
Public title A prospective study of endoscopic diagnosis through the submucosal tunnel for gastrointestinal submucosal tumors
Acronym Endoscopically visualized imaging of gastrointestinal submucosal tumor
Scientific Title A prospective study of endoscopic diagnosis through the submucosal tunnel for gastrointestinal submucosal tumors
Scientific Title:Acronym Endoscopically visualized imaging of gastrointestinal submucosal tumor
Region
Japan

Condition
Condition gastrointestinal submucosal tumors including subepithelial tumors
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore if endoscopically visualized imagings via submucosal tunnel produce a novel classification of GI submucosal tumors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The concordant rate between endoscopic visual diagnosis according to our proposed classification of submucosal tumors and the histological final diagnosis
Key secondary outcomes 1.The rate of endoscopic visualization via submucosal tunnel of submucosal tumors
2.The validity of the classification of submucosal tumors
3.Adverse events

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 Submucosal tunneling biopsy (STB), which offers sufficient specimens of submucosal tumor (SMT) without contamination under direct vision
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 tumors which appear in the submucosa
Key exclusion criteria tumors which do not appear in the submucosa or extraluminally growing tumors by endosonography and computed tomography
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Kobara
Organization Faculty of Medicine, Kagawa University
Division name Gastroenterology and Neurology
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 087-891-2156
Email kobara@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuoka
Organization Faculty of Medicine, Kagawa University
Division name Investigator
Zip code
Address 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 087-898-5111
Homepage URL
Email chosa@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University Hospital
Institute
Department

Funding Source
Organization Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
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
Address
Tel
Email

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
2016 Year 02 Month 03 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
2013 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 01 Day
Last modified on
2017 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024047

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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