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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034189
Receipt No. R000038974
Scientific Title Evaluation of exfoliated tumor cells after spcimen collection for pathology.
Date of disclosure of the study information 2018/09/18
Last modified on 2018/09/18

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Basic information
Public title Evaluation of exfoliated tumor cells after spcimen collection for pathology.
Acronym Evaluation of exfoliated tumor cells after spcimen collection.
Scientific Title Evaluation of exfoliated tumor cells after spcimen collection for pathology.
Scientific Title:Acronym Evaluation of exfoliated tumor cells after spcimen collection.
Region
Japan

Condition
Condition Submucosal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of exfoliated tumor cells after specimen collection for pathology.
Basic objectives2 Others
Basic objectives -Others Evaluation of exfoliated tumor cells in gastric juce after spcimen collection for pathology using EUS-FNA or MIAB.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The percentage of the exfoliated tumor cells.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients with SMT who undergo EUS-FNA or endoscopic mucosal incision assisted biopsy (MIAB), and collected gastri juice.
2. Patients from whom written informed consent is obtained.
3. Patients who are older than 20 years old.
Key exclusion criteria 1. Patients who are judged as contraindication for EUS-FNA or MIAB.
2. Patients who are judged as being inappropriate for this study by their medical doctor.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eikichi Ihara
Organization kyushu univercity hospital
Division name Department of Medicine and Bioregulatory Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 0926425082
Email eikichi@intmed3.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Minoda
Organization Kyushu University Graduate School of Medical Sciences
Division name Department of Medicine and Bioregulatory Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 0926425082
Homepage URL
Email yminoda@med.kyushu-u.ac.jp

Sponsor
Institute kyushu univercity hospital
Institute
Department

Funding Source
Organization None
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
2018 Year 09 Month 18 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
2018 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Obesrvation study

Management information
Registered date
2018 Year 09 Month 18 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038974

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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