UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034607 |
|---|---|
| Receipt number | 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 14:29:47 |
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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
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
toto.rikako@gmail.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039453
