UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676)
Title of the study (Brief title)	Japan Esophageal Cohort study Genetic polymorphism analysis: JEC-G study
Region	Japan

Condition
Condition	Esophageal squamous cell carcinoma
Classification by specialty	Gastroenterology Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	For patients enrolled in clinical trials (UMIN000001676), we evaluate the risk of esophageal cancer and abstinence effect of smoking and drinking alcohol according to ALDH2/ADH1B/CYP2A6 gene polymorphism.
Basic objectives2	Others
Basic objectives -Others	The aim of this study is to investigate the risk of metachronous cancers and assess the period required for their development after endoscopic resection, using Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism in patients with esophageal squamous cell carcinoma after endoscopic resection.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The cumulative incidence of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism
Key secondary outcomes	The total annual number of cases of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism

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	(1) Newly diagnosed early squamous cell carcinoma of the esophagus. (2) Complete endoscopic resection (ER) as assessed visually on Lugol chromoendoscopy immediately after ER. (3) A diagnosis of squamous cell carcinoma on histopathological examination of the resected specimen. (4) Vertical margins of the resected specimen are confirmed to be tumor-negative. (5) Tumor invasion is limited to the mucosa on histopathological examination of the resected specimen, and no additional treatment (surgical resection, radiotherapy, chemotherapy, etc.) is performed immediately after ER. (6) No active head or neck cancers. (7) The investigator judges that patient can be observed for at least 2 years. (8) Written informed consent is obtained from the patient.
Key exclusion criteria	(1) A history of chemotherapy for any other cancers or a history of surgical treatment or radiotherapy for head and neck cancers. (2) A history of iodine allergy. (3) Patients whom the investigator considers unsuitable as subjects for this study.
Target sample size	331

Research contact person
Name of lead principal investigator	Chikatoshi Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL	042-778-8111
Email	ckatada@med.kitasato-u.ac.jp

Public contact
Name of contact person	Chikatoshi Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Address	1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	Grant-in-Aid for Scientific Research
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2018 Year 11 Month 05 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 05 Month 09 Day
Anticipated trial start date	2018 Year 11 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Multicenter cohort study to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma (UMIN000001676)

Management information
Registered date	2018 Year 11 Month 04 Day
Last modified on	2018 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039642