Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma.

Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma. - Study of the involvement of the gut microbiota in the pathophysiology and treatment effect of patients with unresectable hepatocellular carcinoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042709

Enrollment

Registered

2020-12-10

Start date

2020-12-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Evaluation of the composition of the gut microbiota in patients with hepatocellular carcinoma, patients with cirrhosis, and healthy individuals.	—

Secondary

Measure	Time frame
Cytokine and chemokine concentrations in the blood of patients with hepatocellular carcinoma and the ratio of tumor immune-related cells in the blood.	—

Countries

Japan

Contacts

Public ContactTomotake Shirono

Kurume university Gastroenterology

shirono_tomotake@med.kurume-u.ac.jp0942-31-7561

Outcome results