UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022898 |
|---|---|
| Receipt number | R000026388 |
| Scientific Title | Selection of high risk group of gastric cancer development in patients eradicated Helicobacter pylori using expression level of gastric mucosal PSCA/CD44v9: Retrospective multi-center trial |
| Date of disclosure of the study information | 2016/06/28 |
| Last modified on | 2021/06/30 09:56:41 |
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Basic information
Public title
Selection of high risk group of gastric cancer development in patients eradicated Helicobacter pylori using expression level of gastric mucosal PSCA/CD44v9: Retrospective multi-center trial
Acronym
Selection of high risk group of gastric cancer development
Scientific Title
Selection of high risk group of gastric cancer development in patients eradicated Helicobacter pylori using expression level of gastric mucosal PSCA/CD44v9: Retrospective multi-center trial
Scientific Title:Acronym
Selection of high risk group of gastric cancer development
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify efficacy of grading system depended on gastric mucosal expression level of PSCA/CD44v9 in early-stage gastric cancer patients eradicated with H. pylori infection
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation period from endoscopic resection early stage gastric cancer to development of metachronous gastric cancer in early-stage gastric cancer patients eradicated with H. pylori infection
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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. Early stage gastric cancer patients treated with endoscopic resection from Apr 2006 to Mar 2016 and were followed.
2. To check H. pylori infection by urea breath test, rapid urease test, culture or/and IgG.
3. With gastric cancer or adenoma pathologically
4. To be stocked resected gastric cancer.
5. With informed consent to enroll in this study
Key exclusion criteria
1. Patients who cannot check metachronou gastric cancer routinely.
2. patients received chemotherapy
3. with mental disorder
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Shiga University of Medical Science Hospital
Division name
Division of Digestive Endoscopy
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2618
sugimo@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Shiga University of Medical Science Hospital
Division name
Division of Digestive Endoscopy
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2618
Homepage URL
sugimo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science Hospital
Division of Gastroenterology
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
Shiga University of Medical Science Hospital
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel
077-548-2217
hqrec@belle.shiga-med.ac.jp
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
| 2016 | 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
15
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
| 2016 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026388
| 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 |
