UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026154 |
|---|---|
| Receipt number | R000030058 |
| Scientific Title | The contribution of gut microbiome to liver carcinogenesis after SVR |
| Date of disclosure of the study information | 2017/02/15 |
| Last modified on | 2023/03/07 14:50:49 |
* 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
The contribution of gut microbiome to liver carcinogenesis after SVR
Acronym
Gut microbiome and liver carcinogenesis after SVR
Scientific Title
The contribution of gut microbiome to liver carcinogenesis after SVR
Scientific Title:Acronym
Gut microbiome and liver carcinogenesis after SVR
Region
| Japan |
Condition
Condition
HCV infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the contribution of pathological gut microbiome to liver carcinogenesis after SVR.
Basic objectives2
Others
Basic objectives -Others
To clarify the pathway of progression to liver carcinogenesis after SVR induced by pathological gut microbiome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analysis the gut microbiome in the patients with or without liver carcinogenesis after SVR.
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
1. Patients who who will visit as outpatient or be admitted to Nagasaki university hospital.
2. Patients providing written informed consent with their own will.
3. Patients who didn't progress to liver carcinogenesis 5 years after anti-HCV therapy with SVR, or patients who progress to liver carcinogenesis 6 months after anti-HCV therapy with SVR.
Key exclusion criteria
1. Patients with some diffuse lesions in large colon.
2. Patients with severe general complications
3. Patients who were judged to be inappropriate for this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakao |
Organization
Nagasaki University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197481
kazuhiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Miuma |
Organization
Nagasaki University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197481
Homepage URL
miuma1002@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not paticular
Management information
Registered date
| 2017 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030058
