UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005651 |
|---|---|
| Receipt number | R000006646 |
| Scientific Title | Preliminary study of measurement of 8- OHdG in urine in patient with liver disease |
| Date of disclosure of the study information | 2011/05/30 |
| Last modified on | 2013/06/04 16:06:14 |
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Basic information
Public title
Preliminary study of measurement of 8- OHdG in urine in patient with liver disease
Acronym
8- OHdG in the urine of the liver disease
Scientific Title
Preliminary study of measurement of 8- OHdG in urine in patient with liver disease
Scientific Title:Acronym
8- OHdG in the urine of the liver disease
Region
| Japan |
Condition
Condition
chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is examined whether the measurement of the oxidant stress in urine is useful for the forecast of the patient's condition, the prognosis of progress, and carcinogenesis in chronic liver disease patients.
Basic objectives2
Others
Basic objectives -Others
Whether the measurement of the oxidant stress in urine is usefulness for the evaluation of treatment and the prevention is examined.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of an 8- OHdG values in urine is analyzed by using the analysis of variance in chronic hepatitis and cirrhosis and liver cancer patient.
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
None
Key exclusion criteria
None
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Yamamoto |
Organization
Department of Medicine, Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
1-8-13 Kanda-Surugadai Chiyoda-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Surugadai Nihon Univ. Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
1-8-13 Kanda-Surugadai Chiyoda-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Surugadai Nihon Univ. Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology
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
| 2011 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Samples of 37 liver disease patients and 21 healthy persons were analyzed in this study. In the group of liver disease patients and healthy persons, average 8-OHdG/Cr ratio was 1.31 and 0.98, standard error is 13.6 and 17.8 respectively.
The result of student t test was Prob<t 0.0061.
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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 04 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 04 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 04 | Day |
Other
Other related information
An 8- OHdG in urine is measured by the immunochromato graphy.
Management information
Registered date
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2013 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006646
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