Prospective observational cohort study on the correlation of microbiome diversity and oncological outcome in immune checkpoint inhibitor therapy

Prospective observational cohort study on the correlation of microbiome diversity and oncological outcome in immune checkpoint inhibitor therapy - MicrobiomCheckpoint01

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030723

Enrollment

100

Registered

2022-11-11

Start date

2022-11-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C00-C97

Interventions

Group 1: Indicated treatment with a checkpoint inhibitor as a single agent or in combination with another checkpoint inhibitor or another treatment agent or treatment modality (e.g., targeted therapy,

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Voluntarily agree to participate in this study, fully understand the study and sign the informed consent form (ICF). • =18 years old • Are you planning treatment with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) alone or in combination with another checkpoint inhibitor or treatment agent or modality (eg, B. Targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with the use of the active substance approved by the EMA/BfArM • Life expectancy = 6 months • Willingness to provide stool samples for research purposes

Exclusion criteria

Exclusion criteria: • Voluntarily agree to participate in this study, fully understand the study and sign the informed consent form (ICF). • =18 years old • Are you planning treatment with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) alone or in combination with another checkpoint inhibitor or treatment agent or modality (eg, B. Targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with the use of the active substance approved by the EMA/BfArM • Life expectancy = 6 months • Willingness to provide stool samples for research purposes

Design outcomes

Primary

Measure	Time frame
Correlation of the relative frequency of Bacteria at baseline with the objective response rate at the first 3-month follow-up	—

Secondary

Measure	Time frame
Correlation of microbiome composition at baseline vs. objective response rate at first follow-up at 3 months/progression-free survival [time frame: 3-12 months]	—

Countries

Germany

Contacts

Public ContactKatjana Schwab

Rheinische Friedrich-Wilhelms-Universität Bonn

Katjana.Schwab@ukbonn.de++49 228 287-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026