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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023771
Receipt No. R000027374
Scientific Title Identification of circulating microRNAs as a biomarker of mental stress
Date of disclosure of the study information 2016/09/15
Last modified on 2019/11/18

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Basic information
Public title Identification of circulating microRNAs as a biomarker of mental stress
Acronym Identification of circulating microRNAs as a biomarker of mental stress
Scientific Title Identification of circulating microRNAs as a biomarker of mental stress
Scientific Title:Acronym Identification of circulating microRNAs as a biomarker of mental stress
Region
Japan

Condition
Condition gastroesophageal reflux diseases
Classification by specialty
Medicine in general Gastroenterology Psychosomatic Internal Medicine
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identification of circulating microRNAs correlated with the scores of HADS (Hospital Anxiety and Depression Scale), which could be a biomarker of mental stress
Basic objectives2 Others
Basic objectives -Others Evaluation whether the identified stress-associated microRNAs could be associated with the severity or the therapeutic efficacy of gastroesophageal reflux symptoms
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence of circulating microRNAs which are associated with the severity of both mental stress (defined by HADS) and gastroesophageal reflux symptoms (defined by GerdQ)
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

Not applicable
Gender Male and Female
Key inclusion criteria - Patient capable and willing of giving written informed consent
- Outpatient of Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University Hospital
- Patient who underwent esophagogastroduodenoscopy within the past 6 months
- Patient taking proton pump inhibitors for more than 8 weeks for the treatment of gastroesophageal reflux symptoms
Key exclusion criteria - Pregnant women
- Patient who has a history of surgical operation in the esophagus, the stomach, the liver, the gallbladder, or the pancreas
- Patient who underwent Helicobacter pylori eradication therapy within the past 1 year
- Patient who has on organic disease associated with gastrointestinal symptoms, such as malignant diseases
- Patient who has an psychiatric illness, such as schizophrenia and depression
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Ochiya
Organization National Cancer Center Research Institute
Division name Division of Molecular and Cellular Medicine
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email tochiya@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuhiro Masaoka
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email masaoka@keio.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 15 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
2016 Year 08 Month 24 Day
Date of IRB
2016 Year 08 Month 24 Day
Anticipated trial start date
2016 Year 09 Month 15 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Serum samples obtained from PPI-effective or ineffective patients with gastroesophageal reflux symptoms were analyzed by microRNA microarray analysis. Hospital Anxiety and Depression Scale (HADS) was also asked to answer. First, we identify microRNAs, the level of which are correlated with HADS. Second, we evaluate the utility of the identified microRNAs in the medical care for gastroesophageal symptoms.

Management information
Registered date
2016 Year 08 Month 25 Day
Last modified on
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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