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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032516
Receipt No. R000032558
Scientific Title SBP detective marker
Date of disclosure of the study information 2018/05/15
Last modified on 2019/06/06

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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
Email 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
Email kawara@naramed-u.ac.jp

Sponsor
Institute The third department of internal medicine, Nara Medical University
Institute
Department

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
Email 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
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 Enrolling by invitation
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 not started

Management information
Registered date
2018 Year 05 Month 08 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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