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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020261
Receipt No. R000023382
Scientific Title Analysis of submucosal (SM) invasion site of laterally spreading tumor among subtypes
Date of disclosure of the study information 2015/12/18
Last modified on 2016/02/07

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Basic information
Public title Analysis of submucosal (SM) invasion site of laterally spreading tumor among subtypes
Acronym Analysis of submucosal (SM) invasion site of laterally spreading tumor among subtypes
Scientific Title Analysis of submucosal (SM) invasion site of laterally spreading tumor among subtypes
Scientific Title:Acronym Analysis of submucosal (SM) invasion site of laterally spreading tumor among subtypes
Region
Japan

Condition
Condition laterally spreading tumor (LST)
(early colorectal cancer or adenoma)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze the difference of submucosal invasion site among LST subtypes.
Basic objectives2 Others
Basic objectives -Others Retrospective study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the pathological characteristics of submucosal(SM) invasion site and number among LST subtypes.
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. Lesions diagnosed with LST in preoperative endoscopy.
2. Lesions removed by endoscopic or surgical resection.
3. Over 20 years old
4. Written informed consent
Key exclusion criteria 1. Inflammatory bowel disease patient
2. Hereditary colorectal cancer patient
3. Advanced cancer lesion (T2 or more)
4. Impossible pathological evaluation
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Ishigaki
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1 Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL 045-949-7265
Email tomoyuki_ishigaki@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Ishigaki
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1 Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL 045-949-7265
Homepage URL
Email tomoyuki_ishigaki@yahoo.co.jp

Sponsor
Institute Showa University Northern Yokohama 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
2015 Year 12 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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Method)
This study was retrospective study. We included consecutive patients with LSTs according to the criteria between Apr 2010 to Des 2013 that removed by endoscopic or surgical resection at Showa University Northern Yokohama Hospital. The age and sex of patients, tumor size, the location, and the subtype of LST were reviewed from the electronic health record system. The degree of submucosal invasion and the figure and number of submucosal invasion site of LST and was analyzed using pathological specimens.

Management information
Registered date
2015 Year 12 Month 18 Day
Last modified on
2016 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023382

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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