UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter retrospective study on evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in pT1cN0 thoracic esophageal squamous cell carcinoma
Acronym	Evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in thoracic esophageal cancer
Scientific Title	A multicenter retrospective study on evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in pT1cN0 thoracic esophageal squamous cell carcinoma
Scientific Title:Acronym	Evaluation of the risk of lymph node metastasis using CRP genetic polymorphism in thoracic esophageal cancer
Region	Japan

Condition
Condition	pT1cN0 thoracic esophageal squamous cell carcinoma
Classification by specialty	Medicine in general Gastroenterology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the diagnostic ability for the risk of lymph node metastasis using CRP genetic polymorphism in patients with pT1cN0 thoracic esophageal squamous cell carcinoma.
Basic objectives2	Others
Basic objectives -Others	To evaluate the diagnostic ability for the risk of lymph node metastasis using CRP genetic polymorphism
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Negative predictive value to diagnose lymph node metastasis
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. pT1a-MM (ly+ and/or v+) or pT1b, cN0M0 primary thoracic squamous cell esophageal carcinoma. 2. Performed esophagectomy with 2 or 3-field lymph node adenectomy after 2007. 3. Examined lymph node metastasis pathologically. 3. Patients obtained informed consents. 4. Patients who can collect blood at the time of study.
Key exclusion criteria	1. Received neoadjuvant therapy. 2. Had double cancers diagnosed 3 years before or 2 years after esophagectomy. 3. Within 2 years after esophagectomy. 4. Had prior surgery in mediastimun.
Target sample size	645

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Motoyama
Organization	Akita University
Division name	Graduate School of Medicine
Zip code	010-8543
Address	1-1-1 Hondo, Akita
TEL	018-834-1111
Email	motoyama@doc.med.akita-u.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Motoyama
Organization	Akita University
Division name	Graduate School of Medicine
Zip code	010-8543
Address	1-1-1 Hondo, Akita
TEL	018-834-1111
Homepage URL
Email	motoyama@doc.med.akita-u.ac

Sponsor
Institute	Akita University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Independent Ethics Committee of Tohoku University Hospital
Address	1-1 Seiryocho, Aobaku, Sendai
Tel	022-728-4105
Email	ec@rinri.hosp.tohoku.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	2019 Year 09 Month 19 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	No longer recruiting
Date of protocol fixation	2019 Year 09 Month 03 Day
Date of IRB	2019 Year 10 Month 09 Day
Anticipated trial start date	2019 Year 10 Month 17 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 02 Month 25 Day
Date trial data considered complete	2022 Year 03 Month 02 Day
Date analysis concluded	2022 Year 05 Month 30 Day

Other
Other related information	A multicenter retrospective study In this study, we analyze CRP genetic polymorphism using blood sample.

Management information
Registered date	2019 Year 09 Month 18 Day
Last modified on	2022 Year 03 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043356