UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023771 |
|---|---|
| Receipt number | 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 | 2021/07/22 19:14:41 |
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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 | 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
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
masaoka@keio.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
