UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014365 |
|---|---|
| Receipt number | R000016718 |
| Scientific Title | An Explorative Study for Metabolism of the Esophageal Epithelium in the Carcinogenic Process Using Biopsy Samples |
| Date of disclosure of the study information | 2014/06/25 |
| Last modified on | 2017/12/26 20:21:04 |
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Basic information
Public title
An Explorative Study for Metabolism of the Esophageal Epithelium in the Carcinogenic Process Using Biopsy Samples
Acronym
MEEB study
Scientific Title
An Explorative Study for Metabolism of the Esophageal Epithelium in the Carcinogenic Process Using Biopsy Samples
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Atsushi Yagishita |
Organization
National Cancer Center East
Division name
Division of science & technology for endoscopy & surgery
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
ayagishi@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Yagishita |
Organization
National Cancer Center East
Division name
Division of science & technology for endoscopy & surgery
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
ayagishi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center East
Institute
Department
Personal name
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)
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
| 2014 | Year | 06 | Month | 25 | 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
| 2004 | Year | 05 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016718
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
