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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034607
Receipt No. R000039453
Scientific Title Utility of measuring salivary herpes zoster virus in ulcerative colitis
Date of disclosure of the study information 2018/10/24
Last modified on 2018/10/23

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Basic information
Public title Utility of measuring salivary herpes zoster virus in ulcerative colitis
Acronym Utility of measuring salivary herpes zoster virus in ulcerative colitis
Scientific Title Utility of measuring salivary herpes zoster virus in ulcerative colitis
Scientific Title:Acronym Utility of measuring salivary herpes zoster virus in ulcerative colitis
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It was verified whether extraction of DNA in the saliva by VZV real-time PCR method was possible, and VZV (PCR) and herpes zoster IgG, IgM antibody to verify the usefulness of saliva DNA. Diagnosis by saliva is made possible, making it easier to diagnose. If the relationship with disease activity is clarified, risk of shingles development and reactivation by course and treatment is assumed, and it is easy to perform early diagnosis and early treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of VZV detection in serum and saliva in inflammatory bowel disease
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ulcerative colitis
Key exclusion criteria Serious inflammatory bowel disease patients considered to be difficult to collect saliva or endoscopy
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rikako Kinoshita
Organization Nagasaki University Hospital
Division name Gastroenterology
Zip code
Address 1-7-1 Sakamoto, Nagasaki-city, Nagasaki
TEL 095-819-7482
Email toto.rikako@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Rikako Kinoshita
Organization Nagasaki University Hospital
Division name Gastroenterology
Zip code
Address 1-7-1 Sakamoto, Nagasaki-city, Nagasaki
TEL 095-819-7482
Homepage URL
Email toto.rikako@gmail.com

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization Other
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
2018 Year 10 Month 24 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We measured patient background, recorded concomitant medication, observe clinical symptoms, colonoscopy, blood test, VZV IgG, IgM, serum VZV (PCR), saliva VZV (PCR), comparison before and after treatment .

Management information
Registered date
2018 Year 10 Month 23 Day
Last modified on
2018 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039453

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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