UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042709 |
|---|---|
| Receipt number | R000048748 |
| Scientific Title | Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma. |
| Date of disclosure of the study information | 2020/12/10 |
| Last modified on | 2023/01/24 10:40:41 |
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Basic information
Public title
Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma.
Acronym
Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma.
Scientific Title
Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma.
Scientific Title:Acronym
Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the composition of the gut microbiota in patients with hepatocellular carcinoma, patients with cirrhosis, and healthy individuals.
Basic objectives2
Others
Basic objectives -Others
Cytokine and chemokine concentrations in the blood of patients with hepatocellular carcinoma and the ratio of tumor immune-related cells in the blood.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the composition of the gut microbiota in patients with hepatocellular carcinoma, patients with cirrhosis, and healthy individuals.
Key secondary outcomes
Cytokine and chemokine concentrations in the blood of patients with hepatocellular carcinoma and the ratio of tumor immune-related cells in the blood.
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
I. Person who is 20 years old or older at the time of obtaining consent.
II. Person who obtained a written consent.
And
A) Patients with unresectable advanced hepatocellular carcinoma.
1. Patients whose physicians have selected lenvatinib as the optimal treatment.
2. If pre-treatment has been administered, it should be confirmed that the medication is safe in terms of pharmacokinetics.
B) Patients with liver cirrhosis.
1. Persons who have no history of hepatocellular carcinoma treatment during outpatient follow-up at our hospital.
C) Healthy person.
1. Clinically problematic blood diseases, renal diseases, endocrine diseases, lung diseases, gastrointestinal diseases, cardiovascular diseases, Those who do not have a history of liver disease, mental illness or mental illness.
2. Persons who are judged to have no clinical problems as a result of health examination.
Key exclusion criteria
A) Patients with unresectable advanced hepatocellular carcinoma.
1. Patients with decreased hepatic reserve (Child-Pugh class C).
2. Patients with intractable ascites.
3. Patients judged by the principal investigator and the research coordinator to be inappropriate as research subjects.
B) Patients with liver cirrhosis.
1. Patients with decreased hepatic reserve (Child-Pugh class C).
2. Patients with intractable ascites.
3. Patients judged by the principal investigator and the research coordinator to be inappropriate as research subjects.
4. Patients who have been treated with antibacterial drugs due to the appearance of hepatic encephalopathy.
C) Healthy person.
1. Those who are pregnant or breastfeeding, or those who are judged by the principal investigator and the research coordinator to be inappropriate as research subjects.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Torimura |
Organization
Kurume university
Division name
Gastroenterology
Zip code
830-0011
Address
67 Asahimachi, Kurume City, Fukuoka Prefecture
TEL
0942-31-7561
tori@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotake |
| Middle name | |
| Last name | Shirono |
Organization
Kurume university
Division name
Gastroenterology
Zip code
830-0011
Address
67 Asahimachi, Kurume City, Fukuoka Prefecture
TEL
0942-31-7561
Homepage URL
shirono_tomotake@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume university
Institute
Department
Personal name
Funding Source
Organization
There is no funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yakult Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume university
Address
67 Asahimachi, Kurume City, Fukuoka Prefecture
Tel
0942-35-3311
i_rinri@kurume-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to analyze the gut microbiota in patients with advanced HCC, patients with cirrhosis, and healthy individuals to identify differences, and to analyze cytokines and chemokines induced in patients with HCC to identify predictors of therapeutic efficacy of medications approved for advanced HCC (molecularly targeted therapies) and to clarify how the gut microbiota affects tumor immunity.
Management information
Registered date
| 2020 | Year | 12 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048748
