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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||||
Condition | gastroesophageal reflux diseases | ||||
Classification by specialty |
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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 | |
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Stratification | |
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Blocking | |
Concealment |
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Eligibility | ||||
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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 |
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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 |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
tochiya@ncc.go.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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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 |
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |