UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030383 |
|---|---|
| Receipt number | R000034684 |
| Scientific Title | Surveillance of Patients with Barrett's Esophagus for the Incidence of Esophageal Adenocarcinoma: A Multicenter Prospective Study in Akita, Japan |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2017/12/13 14:58:33 |
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Basic information
Public title
Surveillance of Patients with Barrett's Esophagus for the Incidence of Esophageal Adenocarcinoma: A Multicenter Prospective Study in Akita, Japan
Acronym
Barrett's Esophagus Study in Akita
Scientific Title
Surveillance of Patients with Barrett's Esophagus for the Incidence of Esophageal Adenocarcinoma: A Multicenter Prospective Study in Akita, Japan
Scientific Title:Acronym
Barrett's Esophagus Study in Akita
Region
| Japan |
Condition
Condition
esophageal adenocarcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
surveillance of patients with Barrett's esophagus for the incidence of esophageal adenocarcinoma
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 years later after finding Barrett's esophagus
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients who have Barrett's esophagus with a length of at least 1cm
Key exclusion criteria
a patient who had already done the operation of upper GI tract
a patient who cannot be taken biopsy tissues because of some risks
a patient who already have esopageal adenocarcinoma at the first time endoscopy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Koizumi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1-1, Hondo, Akita City, Akita, Japan
TEL
018-884-6104
shigeto@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Koizumi |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-1-1, Hondo, Akita City, Akita, Japan
TEL
018-884-6104
Homepage URL
shigeto@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 12 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study design: multicenter prospective observational study
to investigate the incidence of esophageal adenocarcinoma in patients with Barrett's esophagus by yearly follow-up endoscopic examinations
Management information
Registered date
| 2017 | Year | 12 | Month | 13 | Day |
Last modified on
| 2017 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034684
