UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to elucidate the incidence of SSA/P in serrated lesions of the colorectum
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Wataru Sano
Organization	Sano hospital
Division name	Institute of Minimally-invasive Endoscopic Care (iMEC)
Address	2-5-1, Shimizugaoka, Tarumi, Kobe, Hyogo, Japan
TEL	078-785-1000
Email	watasano@yahoo.co.jp

Public contact
Name of contact person	Wataru Sano
Organization	Sano hospital
Division name	Institute of Minimally-invasive Endoscopic Care (iMEC)
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0034-1391948
Results
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