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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020085
Receipt No. R000023209
Scientific Title Preliminary study of the fine needle aspiration using endoscopic ultrasonography for the colorectal disease
Date of disclosure of the study information 2016/02/01
Last modified on 2021/06/10

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Basic information
Public title Preliminary study of the fine needle aspiration using endoscopic ultrasonography for the colorectal disease
Acronym Aspiration study for the colorectal disease
Scientific Title Preliminary study of the fine needle aspiration using endoscopic ultrasonography for the colorectal disease
Scientific Title:Acronym Aspiration study for the colorectal disease
Region
Japan

Condition
Condition colorectal disease
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 diagnosis for the colorectal disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnositic rate for the colorectal disease
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 EUS, which is approved for only upper GI diseases, is used for colorectal diseases.
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 A. 20 years old or more than 20 years old male and female
B. undiagnosed colorectal yumor
Key exclusion criteria A. age limitations
B. allergy for rubber
C. incomplete informed consent
D. pregnant
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Masanao
Middle name
Last name Nakamura
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code 466-8550
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL +81527442172
Email makamura@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Masanao
Middle name
Last name Nakamura
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 466-8550
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL +81527442172
Homepage URL
Email makamura@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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 Nagoya University ethic committee
Address 65, showa-ku, turumai-cho
Tel 0527442805
Email ethic@med.nagoya-u.ac.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
2016 Year 02 Month 01 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
2015 Year 12 Month 07 Day
Date of IRB
2016 Year 07 Month 07 Day
Anticipated trial start date
2016 Year 07 Month 07 Day
Last follow-up date
2023 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
2015 Year 12 Month 06 Day
Last modified on
2021 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023209

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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