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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025697
Receipt No. R000029546
Scientific Title Outcome analysis after endoscopic resection of esophageal cancer invading into muscularis mucosa or upper part of submucosa.
Date of disclosure of the study information 2017/01/17
Last modified on 2017/01/15

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Basic information
Public title Outcome analysis after endoscopic resection of esophageal cancer invading into muscularis mucosa or upper part of submucosa.
Acronym Outcome analysis after endoscopic resection of esophageal cancer
Scientific Title Outcome analysis after endoscopic resection of esophageal cancer invading into muscularis mucosa or upper part of submucosa.
Scientific Title:Acronym Outcome analysis after endoscopic resection of esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy of endoscopic resection for esophageal cancer invading into MM/SM1 on histologic examination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Histologically diagnosed MM/SM1 esophageal cancer on endoscopically resected specimen.
Key exclusion criteria 1 Clinically confirmed metastasis.
2 Cancers treated with piecemeal resection
3 Incomplete removal of cancer by endoscopic resection
4 Positive or indifinite for vertical margin
5 Recurrence after endoscopic resection
6 Previous radiation to mediastinum
7 Non curative cancer in other organs
8 Past history of esophagectomy or gastrectomy
Target sample size 370

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneo Oyama
Organization Saku Central Hospital Advanced care center
Division name Department of Endoscopy
Zip code
Address 3400-28, Nakagome, Saku city, Nagano, Japan
TEL 0267-62-8181
Email oyama@coral.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryu Ishihara
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Gastrointestinal Oncology
Zip code
Address 1-3-3, Nakamichi, Higashinari-ku, Osaka city, Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email isihara-ry@mc.pref.osaka.jp

Sponsor
Institute Saku Central Hospital Advanced care center
Institute
Department

Funding Source
Organization Self-financed
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 恵佑会第2病院
東北大学
国立がん研究センター中央病院
がん研有明病院
虎ノ門病院
国立がん研究センター東病院
佐久医療センター
静岡がんセンター
大阪府立成人病センター
兵庫県立がんセンター 
岡山大学 
福岡大学筑紫病院

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 17 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
Date of protocol fixation
2017 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 01 Month 16 Day
Last modified on
2017 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029546

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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