Tumor Immunotherapy and Microbiome Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
研究概览
简要总结
The composition of the gut microbiome has been associated with response and the development of toxicities on immune checkpoint inhibitors (ICIs) in multiple tumor types. The aim of this study is to examine the gut microbiome composition in patients undergoing standard of care treatment for advanced/unresectable and/or metastatic solid tumors with ICIs. Fecal samples and peripheral blood samples will be collected to further characterize the diversity of gut bacteria and to study potential mechanisms by which gut bacteria impact the immune response.
详细描述
This is a prospective study of gut microbial markers. Patients with histologically confirmed advanced/unresectable or metastatic solid tumors who are planned to initiate standard of care ICIs or are undergoing standard of care treatment with ICIs will be approached for participation in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign written and voluntary informed consent
- •Adult patients aged >=18, male or female
- •Eastern Cooperative Group (ECOG) performance status 0-2
- •Histologic diagnosis of an advanced/unresectable or metastatic solid tumor
- •Measurable disease as per RECIST 1.1 criteria
- •Be suitable for or receiving ICI treatment
- •Prior immunotherapy allowed
- •Be willing and able to provide fecal and blood specimens for analysis as per protocol
排除标准
- •Subjects with a history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
结局指标
主要结局
Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
时间窗: 12 months
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing; IgA sequencing of fecal samples from patients who develop diarrhea/colitis
Relative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
时间窗: 6 months
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing
次要结局
- Relative abundance of bacterial DNA in peripheral blood samples(6 months)
- Changes in the composition of the intestinal microbiome induced by ICIs(6 months)
- Changes in immune cell subsets in the systemic circulation upon progression on ICIs correlated with changes in microbiome composition(2 years)
- Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition(6 months)