Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer

Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer - Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051705

Enrollment

326

Registered

2023-07-24

Start date

2023-09-30

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

Lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: i. Pathologically or cytologically confirmed metastatic or postoperative recurrent NSCLC or SCLC. ii. 20 years old at the time of informed consent. iii. Planned treatment with immunotherapy including combination regimens and monotherapies as the first immunotherapy. iv. Ability to provide fecal samples. v. Provision of written informed consent.

Exclusion criteria

Exclusion criteria: i. Diseases eligible for definitive chemoradiotherapy. ii. Patients deemed inappropriate for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
The specific composition of the gut microbiome or combination of gut microbes associated with clinical/graphical therapeutic responses to immunotherapy.	—

Secondary

Measure	Time frame
The specific composition of the gut microbiome or combination of gut microbes associated with immune-related adverse events (irAEs) and The diversity of gut microbes associated with irAEs.	—

Countries

Japan

Contacts

Public ContactFumihiro Shoji

National Hospital Organization Kyushu Cancer Center Department of Thoracic Oncology

fumshojifumshoji@gmail.com092-541-3231

Outcome results