UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000032516 |
|---|---|
| Receipt number | R000032558 |
| Scientific Title | SBP detective marker |
| Date of disclosure of the study information | 2018/05/15 |
| Last modified on | 2024/01/04 23:51:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
SBP detective marker
Acronym
SBP detective marker
Scientific Title
SBP detective marker
Scientific Title:Acronym
SBP detective marker
Region
| Japan |
Condition
Condition
Patients with hepatic ascites
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relations between ascitec bacterial DNA and SBP detective markers.
Basic objectives2
Others
Basic objectives -Others
efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The relation between
Key secondary outcomes
The cut off values of various SBP markers.
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
1)Patients over 20 years old
2)Patients obtained written informed consent
3) Life expectancy of at least 4 weeks
4) Adequate organ function
a) Hb>= 8.0g/dL
b) neutrophil: >= 1,500/mm3
c) Platelet: >= 30,000/mm3
d) Total bilirubin:< 4.0 mg/dL
e) ALT and AST: <= within 6 folds of normal limit
f) Serum creatine: <= 2.0 mg/dL
g) Serum natrium: >= 120mEq/L
Key exclusion criteria
14)Patients with drug abuse or psycological disorders
15) Patients concluded to be inappropriate to participate in this study by their physitians
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Sawada |
Organization
Nara Medical University
Division name
The third department of internal medicine
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
0744-22-3051
kawara@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Kawaratani |
Organization
Nara Medical University
Division name
The third department of internal medicine
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kawara@naramed-u.ac.jp
Sponsor or person
Institute
The third department of internal medicine, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
The third department of internal medicine, Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
No
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Nara Medical University
Address
840 Shijo-cho Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-u.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
奈良県立医科大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 15 | 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
not published
Results date posted
| 2024 | Year | 01 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
delayed
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
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
finished
Management information
Registered date
| 2018 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032558
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
