UMIN-CTR Clinical Trial

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 Takahiro Middle name Last name Ochiya
Organization	National Cancer Center Research Institute
Division name	Division of Molecular and Cellular Medicine
Zip code	104-0045
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 Tatsuhiro Middle name Last name Masaoka
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code	160-8582
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	Keio University Research Ethics Committee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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 09 Month 15 Day

Related information
URL releasing protocol	http://www.keio-med.jp/gastro/patient/progress.html
Publication of results	Unpublished

Result
URL related to results and publications	unpublished
Number of participants that the trial has enrolled	85
Results	We compared serum miRNA profiles between patients with GERD who responded to PPI therapy and those who were refractory to PPI therapy (assumed to have a strong predisposition to psychological stress), and were able to identify serum miRNAs that differed between the two groups.
Results date posted	2021 Year 07 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	No significant differences were seen in age, sex, BMI, presence of SSBE, presence of HH, presence of open type atrophy.
Participant flow	not applicable
Adverse events	no adverse events
Outcome measures	Using serum miRNA, the two groups could be discriminated with an accuracy of AUROC 0.8.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2021 Year 07 Month 22 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
2021/07/22	documents-2.pdf

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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