UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005902 |
|---|---|
| Receipt number | R000006979 |
| Scientific Title | MicroRNA as novel markers of chronic gastritis and gastric adenoma with Helicobacter pylori infection |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2016/01/02 00:42:15 |
* 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
MicroRNA as novel markers of chronic gastritis and gastric adenoma with Helicobacter pylori infection
Acronym
MicroRNA as novel markers of chronic gastritis and gastric tumor with Helicobacter pylori infection
Scientific Title
MicroRNA as novel markers of chronic gastritis and gastric adenoma with Helicobacter pylori infection
Scientific Title:Acronym
MicroRNA as novel markers of chronic gastritis and gastric tumor with Helicobacter pylori infection
Region
| Japan |
Condition
Condition
Helicobacter pylori infection gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate expression profile of microRNA of gastric mucosa and gastric tumor with Helicobacter pylori infection
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of microRNA expression between chronic gastritis and gastric tumor
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who need upper gastrointestinal endoscope in some reasons and to whom whether or not Helicobacter pylori was present was determined
Key exclusion criteria
1. Patients with anti-coagulant drugs, anti-platelet aggregation drugs, steroids, and/or non-steroidal anti-inflammatory drugs
2. Patients with severe comorbidity
3. Patients after operation of the stomach and the duodenum
4. Patients with a history of treatment against Helicobacter pylori infection
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mariko Hojo, MD, PhD |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL
03-3813-3111
mhojo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Hojo, MD, PhD |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1Hongo,Bunkyo-ku,Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
mhojo@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology,Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology,Juntendo University School of Medicine
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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Biopsy samples are taken at endoscopic examination, and microRNA expression profile of tissue samples is investigated using microarray.
Management information
Registered date
| 2011 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006979
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
