UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An Explorative Study for Metabolism of the Esophageal Epithelium in the Carcinogenic Process Using Biopsy Samples
Title of the study (Brief title)	MEEB study
Region	Japan

Condition
Condition	esophageal squamous cell carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clarify the differences of metabolites between normal epithelium, precancerous lesions and cancerous lesions
Basic objectives2	Others
Basic objectives -Others	Description of metabolic nature
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Metabolites recognized in normal epithelium, precancerous lesions and cancerous lesions, and amount of metabolites recognized in each lesion
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) Patients with early esophageal squamous cell carcinoma 2) Alcohol drinker 3) Patients with non-cancerous lugol voiding lesions in the esophagus in chromo-endoscopy
Key exclusion criteria	1) patients with history of chemotherapy 2) patients with history of radiotherapy where the esophagus was irradiated 3) patients with history of radical surgery of head and neck cancer or gastric cancer (not including local resection) 4) patients with allergy to iodine (lugol) 5) patients who are currently treated with steroid hormone
Target sample size	20

Research contact person
Name of lead principal investigator	Atsushi Yagishita
Organization	National Cancer Center East
Division name	Division of science & technology for endoscopy & surgery
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Email	ayagishi@east.ncc.go.jp

Public contact
Name of contact person	Atsushi Yagishita
Organization	National Cancer Center East
Division name	Division of science & technology for endoscopy & surgery
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	ayagishi@east.ncc.go.jp

Sponsor
Institute	National Cancer Center East
Institute
Department

Funding Source
Organization	Japan Science and Technology
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	2014 Year 06 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2004 Year 05 Month 02 Day
Anticipated trial start date	2004 Year 06 Month 11 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	Enrollment is finished.

Management information
Registered date	2014 Year 06 Month 24 Day
Last modified on	2017 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016718