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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010136
Receipt No. R000010772
Scientific Title Prospective cohort study evaluating the long-term outcome after endoscopic submucosal dissection for colorectal neoplasia.
Date of disclosure of the study information 2013/02/28
Last modified on 2020/10/15

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Basic information
Public title Prospective cohort study evaluating the long-term outcome after endoscopic submucosal dissection for colorectal neoplasia.
Acronym Long-term outcome after colorectal ESD.
Scientific Title Prospective cohort study evaluating the long-term outcome after endoscopic submucosal dissection for colorectal neoplasia.
Scientific Title:Acronym Long-term outcome after colorectal ESD.
Region
Japan

Condition
Condition Colorectal neoplasia can be treated endoscopically
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the long-term outcome after ESD for colorectal neoplasia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes % 5-year survival without surgical resection in patients with pathological curative resection, % 5-year survival, proportion of one-piece resection, local recurrence, adverse effects
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients who undergo colorectal ESD.
Key exclusion criteria none
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Saito
Organization National cancer center hospital
Division name Endoscopy
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuoku, Tokyo, Japan
TEL 03-3542-2511
Email ytsaito@ncc.go.jp

Public contact
Name of contact person
1st name Nozomu
Middle name
Last name Kobayashi
Organization Tochigi cancer center
Division name Diagnostic imaging
Zip code 320-0834
Address 4-9-13 Yonan, Utsunomiya, Tochigi, Japan
TEL 028-658-5151
Homepage URL
Email nkobayas@tcc.pref.tochigi.lg.jp

Sponsor
Institute National cancer center hospital
Institute
Department

Funding Source
Organization National cancer center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tochigi Cancer Center
Address 4-9-13 Yonan, Utsunomiya, Tochigi, Japan
Tel 028-658-5151
Email chiken@tcc.pref.tochigi.lg.jp

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
2013 Year 02 Month 28 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
2012 Year 08 Month 31 Day
Date of IRB
2013 Year 02 Month 14 Day
Anticipated trial start date
2013 Year 02 Month 28 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 10 Month 15 Day
Date analysis concluded

Other
Other related information All patients who undergo colorectal ESD are enrolled before treatment and will follow for 5 years, prospectivily.

Management information
Registered date
2013 Year 02 Month 28 Day
Last modified on
2020 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/10/15 20201009斎藤班:大腸ESD長期予後研究(UMIN固定).xlsx


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