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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033164
Receipt No. R000037782
Scientific Title Impact of impaired barrier function of esophageal squamous epithelium by acetaldehyde and ethanol on carcinogenesis of esophageal squamous cell carcinoma (ESCC)
Date of disclosure of the study information 2018/06/28
Last modified on 2018/12/27

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Basic information
Public title Impact of impaired barrier function of esophageal squamous epithelium by acetaldehyde and ethanol on carcinogenesis of esophageal squamous cell carcinoma (ESCC)
Acronym Esophageal acetaldehyde/ethanol study
Scientific Title Impact of impaired barrier function of esophageal squamous epithelium by acetaldehyde and ethanol on carcinogenesis of esophageal squamous cell carcinoma (ESCC)
Scientific Title:Acronym Esophageal acetaldehyde/ethanol study
Region
Japan

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

Objectives
Narrative objectives1 To clarify the mechanism of carcinogenesis of ESCC, focusing on esophageal mucosal barrier dysfunction by acetaldehyde and ethanol
Basic objectives2 Others
Basic objectives -Others Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Barrier dysfunction of esophageal squamous epithelium in biopsy specimen exposed by acetaldehyde +/- ethanol in patients with and without ESCC
Key secondary outcomes 1) Level of tight junction protein (TJP)/adhesion junction protein (AJP) in biopsy specimen of esophagus in patients with and without ESCC
2) Level of TJP/AJP RNA in biopsy specimen of esophagus in patients with and without ESCC
3) Oxidative stress marker, endogenous oxidase, and microRNA level in biopsy specimen of esophagus in patients with and without ESCC
4) The relationship between the barrier dysfunction of esophageal squamous epithelium and the amount of drinking and smoking or ALDH2/ADH1B polymorphism

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Measuring barrier function of esophageal squamous epithelium in patients with ESCC, using mini-Ussing chamber system
Interventions/Control_2 Measuring barrier function of esophageal squamous epithelium in patients without ESCC, using mini-Ussing chamber system
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 Patients with ESCC
(1) The patients with superficial ESCC who will receive endoscopic resection
(2) The patients with Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0-1
(3) The patients with aged 20 years or more
(4) The Patients who agreed with informed consent

Control
(1) The patients with early gastric cancer who will receive endoscopic resection
(2) The patients without ESCC
(3) The patients with ECOG-PS of 0-1
(4) The patients whose age and gender is matched with those with ESCC
(5) The patients written informed consent
Key exclusion criteria (1) Patients with regular use of NSAIDs, steroids, or immunosuppressive agents
(2) Patients with a history or a plan of surgery for esophagus, stomach, or duodenum
(3) Patients with a history of chemotherapy or radiation therapy against head and neck or esophageal cancers
(4) Patients with regular use of two or more anticoagulant or antiplatelet medication
(5) Patients with severe systemic diseases
(6) Pregnant or breastfeeding women
(7) Patients who participated in another studies with esophageal biopsies
(8) Patients with severe mental disease
(9) Patients who are judged inappropriate to entry the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Koike
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7171
Email tkoike@rd5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Waku Hatta
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7171
Homepage URL
Email waku-style@festa.ocn.ne.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 06 Month 28 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
2018 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 27 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037782

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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