UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043783 |
|---|---|
| Receipt number | 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 13:45:18 |
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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
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
ohno.hns@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049732
