Prospective observational cohort study on the correlation of microbiome diversity and oncological outcome in immune checkpoint inhibitor therapy
- Conditions
- C00-C97Malignant neoplasms
- Registration Number
- DRKS00030723
- Lead Sponsor
- Rheinische Friedrich-Wilhelms-Universität Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
• 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
• 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of the relative frequency of Bacteria at baseline with the objective response rate at the first 3-month follow-up
- Secondary Outcome Measures
Name Time Method 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]