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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010832
Receipt No. R000012613
Scientific Title Study to elucidate the incidence of SSA/P in serrated lesions of the colorectum
Date of disclosure of the study information 2013/06/01
Last modified on 2016/04/13

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Basic information
Public title Study to elucidate the incidence of SSA/P in serrated lesions of the colorectum
Acronym SSA/P Study
Scientific Title Study to elucidate the incidence of SSA/P in serrated lesions of the colorectum
Scientific Title:Acronym SSA/P Study
Region
Japan

Condition
Condition SSA/P
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the incidence of SSA/P in serrated lesions of the colorectum.
Basic objectives2 Others
Basic objectives -Others To elucidate the incidence of SSA/P in serrated lesions of the colorectum.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of SSA/P in serrated lesions of the colorectum.
Key secondary outcomes Macroscopic features and malignant potential of SSA/P.

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients aged 40 and over
Key exclusion criteria Patients with a history of polypectomy for colorectal serrated polyps.
Patients with a history of colectomy or rectectomy.
Patients with inflammatory bowel disease.
Patients with a family history of colorectal polyposis or HNPCC.
Patients with colorectal polyposis or HNPCC.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Sano
Organization Sano hospital
Division name Institute of Minimally-invasive Endoscopic Care (iMEC)
Zip code
Address 2-5-1, Shimizugaoka, Tarumi, Kobe, Hyogo, Japan
TEL 078-785-1000
Email watasano@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wataru Sano
Organization Sano hospital
Division name Institute of Minimally-invasive Endoscopic Care (iMEC)
Zip code
Address 2-5-1, Shimizugaoka, Tarumi, Kobe, Hyogo, Japan
TEL 078-785-1000
Homepage URL
Email watasano@yahoo.co.jp

Sponsor
Institute Sano 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 佐野病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0034-1391948
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 Completed
Date of protocol fixation
2013 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 03 Day
Last follow-up date
2014 Year 05 Month 30 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information Prospective study

Management information
Registered date
2013 Year 05 Month 29 Day
Last modified on
2016 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012613

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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