UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033165 |
|---|---|
| Receipt number | R000037801 |
| Scientific Title | The relationship between level of lugol-staining of esophageal squamous epithelium (risk for incidence of esophageal squamous cell carcinoma (ESCC)) and impaired barrier function by acetaldehyde |
| Date of disclosure of the study information | 2018/06/28 |
| Last modified on | 2018/06/28 13:39:11 |
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Basic information
Public title
The relationship between level of lugol-staining of esophageal squamous epithelium (risk for incidence of esophageal squamous cell carcinoma (ESCC)) and impaired barrier function by acetaldehyde
Acronym
Esophageal acetaldehyde study
Scientific Title
The relationship between level of lugol-staining of esophageal squamous epithelium (risk for incidence of esophageal squamous cell carcinoma (ESCC)) and impaired barrier function by acetaldehyde
Scientific Title:Acronym
Esophageal acetaldehyde study
Region
| Japan |
Condition
Condition
Superficial ESCC
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the impact of esophageal mucosal barrier dysfunction by acetaldehyde on carcinogenesis of ESCC by comparing lugol-voiding lesion (LVL) and esophageal normal squamous epithelium (ENSE) in patients with ESCC
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Esophageal mucosal barrier dysfunction in biopsy specimens of ENSC and LVL, which are exposed by acetaldehyde
Key secondary outcomes
1)Level of tight junction protein (TJP)/adhesion junction protein (AJP) in biopsy specimens of ENSE and LVL
2)Level of TJP/AJP RNA in biopsy specimens of ENSE and LVL
3)Oxidative stress marker, endogenous oxidase, and microRNA level in biopsy specimens of ENSE and LVL
4)The relationship between the epithelial barrier dysfunction and the amount of drinking and smoking or ALDH2/ADH1B polymorphism in biopsy specimens of ENSE and LVL
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 esophageal mucosal barrier function in ENSE in patients with ESCC, using mini-Ussing chamber system
Interventions/Control_2
Measuring esophageal mucosal barrier function in LVL in patients with 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
(1)The patients with superficial ESCC who will receive endoscopic resection
(2)The patients with Eastern Cooperative Oncology Group performance status of 0-1
(3)The patients with aged 20 years or more
(4)The patients who agreed with 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
20
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
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
waku-style@festa.ocn.ne.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology, 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
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
Preinitiation
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 | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037801
