The analysis of the microbiota as biomarkers of response to anticancer drugs in metastatic solid cancers

The analysis of the microbiota as biomarkers of response to anticancer drugs in metastatic solid cancers - The analysis of Microbiota in the efficacy of anticancer drugs

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030778

Enrollment

Registered

2018-01-12

Start date

2018-01-12

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

Advanced or recurrent cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Age of more than 20 years old. (2) Written informed consent.

Exclusion criteria

Exclusion criteria: (1)Serological positive for HBs antigen, HCV antibody, or HIV antibody (2) An inappropriate case judged by doctor in charge.

Design outcomes

Primary

Measure	Time frame
To identify oral and gut microbiota signatures for responders and nonresponders to anticancer drugs.	—

Secondary

Measure	Time frame
Progression-free survival. Overall survival Oral and gut microbiota signatures for patients with early tumor shrinkage Oral and gut microbiota signatures for adverse event To identify species of intratumor bacteria 12-month PFS rate in cancer patients with or without intratumor bacteria Relationship intratumor bacteria and cancer tissue expression of immune-related proteins Detection of bacterial 16S rRNA in human blood Plasma levels of cytokines or chemokines associated with microbiota signatures Immune cell subsets in peripheral blood analysis by flow cytometry	—

Measure

Time frame

Progression-free survival. Overall survival Oral and gut microbiota signatures for patients with early tumor shrinkage Oral and gut microbiota signatures for adverse event To identify species of intratumor bacteria 12-month PFS rate in cancer patients with or without intratumor bacteria Relationship intratumor bacteria and cancer tissue expression of immune-related proteins Detection of bacterial 16S rRNA in human blood Plasma levels of cytokines or chemokines associated with microbiota signatures Immune cell subsets in peripheral blood analysis by flow cytometry

—

Countries

Japan

Contacts

Public ContactKazuyuki Hamada

Showa University Department of Internal Medicine, Division of Medical Oncology

amadakaz@med.showa-u.ac.jp03-3784-8402

Outcome results