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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043783
Receipt No. R000049732
Scientific Title National Survey on the Treatment of Cervical Esophageal Cancer
Date of disclosure of the study information 2021/03/30
Last modified on 2021/09/29

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Basic information
Public title National Survey on the Treatment of Cervical Esophageal Cancer
Acronym National Survey on the Treatment of Cervical Esophageal Cancer
Scientific Title National Survey on the Treatment of Cervical Esophageal Cancer
Scientific Title:Acronym National Survey on the Treatment of Cervical Esophageal Cancer
Region
Japan

Condition
Condition cervical esophageal cancer
Classification by specialty
Gastrointestinal surgery Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Elucidation of the current status of cervical esophageal cancer treatment in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
Key secondary outcomes larynx preserving rate

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 A case of cervical esophageal cancer treated with radical therapy.
Key exclusion criteria Cases in which the larynx was not preserved before treatment.
Principle investigators considered inappropriate for eligibility.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Asakage
Organization Tokyo Medical and Dental University
Division name Department of Head and Neck Surgery
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku,Tokyo, JAPAN
TEL +81-3-5803-5911
Email tasakage@gmail.com

Public contact
Name of contact person
1st name Kazuchika
Middle name
Last name Ono
Organization Tokyo Medical and Dental University
Division name Department of Head and Neck Surgery
Zip code 113-8519
Address 1-5-45, Yushima, Bunkyo-ku,Tokyo, JAPAN
TEL +81-3-5803-5911
Homepage URL
Email ohno.hns@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization none
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 Medical Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku,Tokyo, JAPAN
Tel +81-3-5803-4085
Email info.bec@tmd.ac.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
2021 Year 03 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 300
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
2019 Year 10 Month 30 Day
Date of IRB
2019 Year 11 Month 22 Day
Anticipated trial start date
2020 Year 01 Month 04 Day
Last follow-up date
2021 Year 02 Month 01 Day
Date of closure to data entry
2021 Year 02 Month 01 Day
Date trial data considered complete
2021 Year 02 Month 01 Day
Date analysis concluded
2021 Year 09 Month 01 Day

Other
Other related information none

Management information
Registered date
2021 Year 03 Month 30 Day
Last modified on
2021 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049732

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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