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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029470
Receipt No. R000033646
Scientific Title Submucosal Fibrosis Prediction in Colorectal Tumor undergoing ESD
Date of disclosure of the study information 2017/11/30
Last modified on 2017/10/08

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Basic information
Public title Submucosal Fibrosis Prediction in Colorectal Tumor undergoing ESD
Acronym Fibrosis in colorectal ESD
Scientific Title Submucosal Fibrosis Prediction in Colorectal Tumor undergoing ESD
Scientific Title:Acronym Fibrosis in colorectal ESD
Region
Japan

Condition
Condition Endoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the predictive factors for presence of severe submucosal fibrosis(F2) in colorectal tumor undergoing ESD
Basic objectives2 Others
Basic objectives -Others To evaluate clinical outcome of ESD in patients with severe fibrosis
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Predictive factors for presence of severe submucosal fibrosis(F2) in colorectal tumor undergoing ESD
Key secondary outcomes Clinical outcome of ESD in patients with severe fibrosis

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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing colorectal ESD following the indication proposed by JGES
Key exclusion criteria 1. Patients who have recurrent colorectal tumor on prior EMR or ESD site
2. Patients with tumors associated with chronic intestinal inflammation conditions, including ulcerative colitis
3. Patients with hyperplastic polyps, inflammatory polyps and neuroendocrine tumors
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uayporn Kaosombatwattana
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
TEL 0527442172
Email koigi214@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Uayporn Kaosombatwattana
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550
TEL 0527442172
Homepage URL
Email koigi214@gmail.com

Sponsor
Institute Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology
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 Nagoya University Hospital (Aichi)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 30 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
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective chart review

Management information
Registered date
2017 Year 10 Month 08 Day
Last modified on
2017 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033646

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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