UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004004 |
|---|---|
| Receipt number | R000004384 |
| Scientific Title | The developmental mechanisms of gastric cancer and esophageal adenocarcinoma |
| Date of disclosure of the study information | 2010/08/06 |
| Last modified on | 2017/11/17 20:00:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Acronym
The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Scientific Title
The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Scientific Title:Acronym
The developmental mechanisms of gastric cancer and esophageal adenocarcinoma
Region
| Japan | North America |
Condition
Condition
gastric cancer,esophageal adenocarcinoma
Barrett's esophageal epithelium
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the genes causing elongation of Barrett's esophageal epithelium and subsequent development of gastric cancer after endoscopic resection and H. pylori eradication
Basic objectives2
Others
Basic objectives -Others
To identify the risk markers related with elongation of Barrett's esophageal epithelium and subsequent development of gastric cancer after endoscopic resection and H. pylori eradication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genes expressions including the micro RNA in the patients with Barrett's esophageal epithelium or gastric cancer after endoscopic resection before and after H. pylori eradication
Key secondary outcomes
comparison of gene expression in the Barrett epithelium between American and Japanese
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
H. pylori eradication
triple therapy 1 week
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
The patients with Barrett's esophageal epithelium and the patietns with endoscopic resection for early gastric cacner and H. pylori eradication
Key exclusion criteria
taking NSAIDs
history of gastrectomy or eradication
haemorrhagic diseases
insulin dependent diabetes mellitus cirrhosis
renal failure
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577,Matsushima,Kurashiki,Okayama
TEL
81864624444
shiotani@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577,Matsushima,Kurashiki,Okayama
TEL
81-86-462-1111
Homepage URL
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2010 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 06 | Day |
Last modified on
| 2017 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004384
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
