Rectal Microbiome Variability Among Rectal Cancer Cohorts Including Complete Clinical Responders, Pathologic Responders, and Early Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- 16s rRNA gene sequencing to study bacterial phylogeny and taxonomy
研究概览
简要总结
The purpose of our study is to determine if an association exists between the microbiome of those with rectal adenocarcinoma who are complete pathologic responders and those who have a partial or no response to neoadjuvant therapy.
详细描述
This study will help to further elucidate the association of bacteria with rectal cancer, while also characterizing the genes associated with that risk. Furthermore it will attempt to better understand which patients may have an optimal response to neoadjuvant chemoradiation allowing for possible predictive metagenomics evaluation, investigators may be able to augment treatments as well as provide recommendations for the success and cost effectiveness of cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Age ≥ 18 years old
- •Locally Advanced Rectal Adenocarcinoma (T3)
- •Standard 5FU based chemoradiation
- •Total Neoadjuvant Therapy per OPRA protocol guidelines
排除标准
- •Age < 18 years
- •Stage I or Stage IV rectal adenocarcinoma
- •Rectal cancer other than adenocarcinoma
- •Genetically associated cancer (HNPCC, FAP etc.) or highly suspicious for genetically associated cancer
- •Prior history of rectal adenocarcinoma (i.e. recurrent colorectal adenocarcinoma)
结局指标
主要结局
16s rRNA gene sequencing to study bacterial phylogeny and taxonomy
时间窗: 5 years
16s rRNA sequencing from biopsy specimens
次要结局
- rectal microbiota to study bacteria strains(5 years)