UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034339 |
|---|---|
| Receipt number | R000039100 |
| Scientific Title | Relation between reflux of duodenal fluid into the stomach and Helicobacter pylori infection-negative gastric cancer. |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/10/01 11:58:10 |
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Basic information
Public title
Relation between reflux of duodenal fluid into the stomach and Helicobacter pylori infection-negative gastric cancer.
Acronym
Relation between reflux of duodenal fluid into the stomach and Helicobacter pylori infection-negative gastric cancer.
Scientific Title
Relation between reflux of duodenal fluid into the stomach and Helicobacter pylori infection-negative gastric cancer.
Scientific Title:Acronym
Relation between reflux of duodenal fluid into the stomach and Helicobacter pylori infection-negative gastric cancer.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of factors that predict the onset of gastric cancer and carcinogenesis in H.pylori infection - negative patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between bile acid and gastric cancer.
Key secondary outcomes
Relationship between carcinogenesis of gastric cancer and non-targeted metabolites
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 diagnosed with gastric cancer
2. There is no restriction on Helicobacter pylori status
Key exclusion criteria
1. Patient with difficult endoscopic examination
2. Patients with poor general condition (PS 3 or higher)
3. A patient who is difficult to draw blood when planning blood sampling.
A case requiring blood transfusion after blood collection.
(Patients with Hb less than 7 g / dl)
4. Patients who judged that researchers are not appropriate as research subjects.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Ogawa |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1, Maedashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
yogawa@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | EIkichi Ihara |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1, Maedashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5286
Homepage URL
eikichi@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Self funding
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 | 10 | Month | 01 | 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
| 2018 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | 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
Age, sex, height, weight, past medical history
Blood test result
Endoscopic observation findings
Pathological diagnosis
Stomach solution (duodenal liquid reflux, bile acid)
Blood microvesicles
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039100
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
