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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032138
Receipt No. R000036276
Scientific Title Multicenter Study for Clarified Clinicopathological Characteristics for Serrated Polyposis Syndrome
Date of disclosure of the study information 2018/04/13
Last modified on 2018/04/06

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Basic information
Public title Multicenter Study for Clarified Clinicopathological Characteristics for Serrated Polyposis Syndrome
Acronym Investigation for Serrated Polyposis Syndrome
Scientific Title Multicenter Study for Clarified Clinicopathological Characteristics for Serrated Polyposis Syndrome
Scientific Title:Acronym Investigation for Serrated Polyposis Syndrome
Region
Japan

Condition
Condition serrated polyposis syndrome
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify clinicopathological features for serrated polypossyndrome
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Clinicopathological features for serrated polyposis syndrome
Key secondary outcomes Detection rate for serrated polyposis syndrome

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with serrated polyposis syndrome patients from 15 institutes affiliated with the Gastroenterological Polyposis Study Group
Key exclusion criteria underage
Target sample size 132

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Tanaka
Organization Hiroshima University Hospital
Division name Department of Endoscopy
Zip code
Address 1-2-3, Kasumi Minami-ku, Hiroshima, Hiroshima, Japan
TEL 082-257-5538
Email colon@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Urabe
Organization Hiroshima University Hospital
Division name epartment of Regeneration and Medicine, Medical Center for translational and Clinical Research
Zip code
Address 1-2-3, Kasumi Minami-ku, Hiroshima, Hiroshima, Japan
TEL 082-257-5955
Homepage URL
Email beyan13@hiroshima-u.ac.jp

Sponsor
Institute Department of Endoscopy
Hiroshima University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 04 Month 13 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 04 Month 06 Day
Last modified on
2018 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036276

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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