NCT05821582撤回不适用
Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
Sanguine Biosciences1 个研究点 分布在 1 个国家开始时间: 2023年3月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Primary Objective- Intestinal side effects of chemotherapy
研究概览
简要总结
The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
详细描述
STUDY DESIGN:
- This protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. The cohort is as follows:
- Cohort 1: Colorectal Cancer: (n=8)
- The study will enroll participants per the eligibility criteria.
- Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). The biospecimens collected from participants on this study are stool samples.
- Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Objective- Intestinal side effects of chemotherapy
时间窗: 8 months
The primary objective of the study is to collect stool samples to provide to the sponsor so the sponsor can assess whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
次要结局
未报告次要终点
研究者
研究点 (1)
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