Gut Microbiome and Oral Fluoropyrimidine Study in Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment rate rate (percentage of patients approached that consent to participate)
研究概览
简要总结
This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer
详细描述
This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer (CRC). Three patient cohorts will be followed. Cohort A: patients treated with oral fluoropyrimidine CAP as part of standard of care (SOC) chemotherapy. Cohort B: patients treated with TAS-102 including those receiving it in combination with Y-90 radioembolization as part of a clinical trial. Cohort C: patients receiving CAP plus immunotherapy (pembrolizumab) and bevacizumab as part of a clinical trial. Investigators will replace participants as needed to ensure a minimum of 10 evaluable participants per cohort (or minimum total of 30 evaluable patients). Evaluable participants are defined as patients with two analyzable stool samples including a baseline sample and at least one on-treatment sample to be used in endpoint analysis
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
- •The patient has histologically proven colorectal adenocarcinoma
- •The patient is starting treatment with oral fluoropyrimidine therapy: CAP or TAS-102 as SOC or on a clinical trial. This also includes those patients receiving treatment in the adjuvant setting or post-metastasectomy with no evidence of disease on imaging.
- •Combination of oral fluoropyrimidine with other cancer-directed therapies, including oxaliplatin, bevacizumab, Y-90 radioembolization, or immunotherapy checkpoint inhibitors, is permitted.
- •Combination of CAP with concurrent radiation is permitted, including patients undergoing radiotherapy to a rectal primary or a metastatic site.
- •Male or female patient aged 18 years of age or older at the time of obtaining the signed and dated informed consent (no upper age limit).
- •Be able to read and speak English.
- •Be willing and able to provide written informed consent for the study
排除标准
- •Patient has had prior chemotherapy, biologic or immunotherapy in the previous 2 weeks.
- •Patient has completed a course of antibiotics longer than 2 weeks in preceding six months or a course of antibiotics of any duration in the 4 weeks prior to starting oral chemotherapy. Any patient who requires treatment with antibiotics during the study may be removed at the investigator's discretion.
- •Known HIV positive.
结局指标
主要结局
Recruitment rate rate (percentage of patients approached that consent to participate)
时间窗: Up to 2 years
Feasibility and acceptability will be assessed by evaluating percentage of patients approached that consent to participate
Reasons for nonparticipation/non-continuation of the study and adherence of submission of stool specimens
时间窗: Up to 2 years
Feasibility and acceptability will be assessed by evaluating reasons for nonparticipation/non-continuation of the study and adherence of submission of stool specimens
Dietary Assessment Questionnaires
时间窗: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, at discontinuation of treatment (an average of 6 months)
Baseline questionnaires regarding bowel habits and dietary history. Patients will complete a 3-day diet record (Automated SelfAdministered 24-Hour (ASA24®) Dietary Assessment Tool or on paper) at the beginning of each treatment cycle when stool is collected. For mid-cycle or toxicity-related stool collections, patients will complete a 24-hour diet recall using the ASA24 system
Acceptability of specimens for analysis
时间窗: Up to 6 months
Specimens collected via Fecal occult blood test (FOBT) card method will be verified as evaluable defined as patients with two analyzable stool samples including a baseline sample and at least one on-treatment sample to be used in endpoint analysis.
次要结局
- Change in gut microbiome diversity(Up to 2 years)
- Change in relative abundance of following gut bacteria that occur with oral fluoropyrimidine therapy(Up to 2 years)