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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002047
Receipt No. R000002492
Scientific Title A phase II trial of endoscopic submucosal dissection (ESD) for superficial esophageal cancer (KDOG 0901)
Date of disclosure of the study information 2009/06/04
Last modified on 2015/04/29

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Basic information
Public title A phase II trial of endoscopic submucosal dissection (ESD) for superficial esophageal cancer (KDOG 0901)
Acronym A phase II trial of ESD for superficial esophageal cancer (KDOG 0901)
Scientific Title A phase II trial of endoscopic submucosal dissection (ESD) for superficial esophageal cancer (KDOG 0901)
Scientific Title:Acronym A phase II trial of ESD for superficial esophageal cancer (KDOG 0901)
Region
Japan

Condition
Condition Superficial esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD)for superficial esophageal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete en bloc resection rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic Submucosal Dissection (ESD)
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 Patients with superficial esophageal cancer who agreed with written informed consent
Key exclusion criteria 1. Active synchronous or metachronous malignancy
2. Severe concomitant disease
3. Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Tanabe
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University School of Medicine, Department of Gastroenterology
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
2009 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2009 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 04 Day
Last modified on
2015 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002492

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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