UMIN-CTR Clinical Trial

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
Email	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
Email	murakami2621@chiba-u.jp

Sponsor
Institute	The Japan Esophageal Society
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054160