UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047504 |
|---|---|
| Receipt number | R000054160 |
| Scientific Title | The prognostic efficacy of lymph node dissection at each lymph node station for cervical esophageal cancer |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2022/04/16 17:53:17 |
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Basic information
Public title
The prognostic efficacy of lymph node dissection at each lymph node station for cervical esophageal cancer
Acronym
The prognostic efficacy of lymph node dissection at each lymph node station for cervical esophageal cancer
Scientific Title
The prognostic efficacy of lymph node dissection at each lymph node station for cervical esophageal cancer
Scientific Title:Acronym
The prognostic efficacy of lymph node dissection at each lymph node station for cervical esophageal cancer
Region
| Japan |
Condition
Condition
Cervical esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prognostic efficacy of lymph node dissection at each lymph node station and propose the optimal extent of lymph node dissection for cervical esophageal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
This study contains two different parts: one using the comprehensive registry (A) and one using a questionnaire survey (B).
(A) The efficacy index at each lymph node station for cervical esophageal cancer
(B) The efficacy index at each lymph node station according to tumor location for cervical esophageal cancer
Key secondary outcomes
The prognostic factors
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
Cervical esophageal cancer
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Murakami |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Frontier Surgery
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
81-43-226-2110
murakami2621@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Murakami |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Frontier Surgery
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
81-43-226-2110
Homepage URL
murakami2621@chiba-u.jp
Sponsor or person
Institute
The Japan Esophageal Society
Institute
Department
Personal name
Funding Source
Organization
The Japan Esophageal Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
81-43-226-2462
inohana-rinri@chiba-u.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
千葉大学大学院医学研究院 先端応用外科（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Multi-institutional retrospective study
Management information
Registered date
| 2022 | Year | 04 | Month | 16 | Day |
Last modified on
| 2022 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054160
