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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name