Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- association of the gut microbiome and dietary factors (To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses)
研究概览
简要总结
The purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. The investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. The investigators will also collect a questionnaire about diet and lifestyle. The samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.
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
- •Male or Female age 18 or older
- •Hereditary colorectal cancer syndrome with one of the following:
- •Lynch syndrome, as defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes
- •Other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (APC, biallelic MYH, STK11, SMAD4, BMPR1A, or other CRC-risk associated genes at discretion of PI)
排除标准
- •Unable to provide informed consent for testing
- •Unable to complete English language questionnaire
- •Receiving active chemotherapy
- •Having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy
- •No infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy
- •No history of inflammatory colitis (Crohn's disease or ulcerative colitis)
研究组 & 干预措施
patients having lower endoscopy
At least 2 weeks prior to scheduled lower endoscopy, consented study participants will be mailed a Brief Diet and Lifestyle Questionnaire, a stool collection kit with detailed instructions and a Stool Collection Data Sheet. No more than one week prior to the lower endoscopy but prior to initiation of bowel preparation, the consented participants will provide a stool specimen and fill out the two questionnaires. The routine lower endoscopy will be performed according to routine clinical procedures. Clinical biopsies of suspicious areas and/or lesions will be taken as per standard clinical care with all such tissue samples sent to pathology for routine clinical analysis. For the sole purposes of research, at the routine lower endoscopy, up to 8 additional colonic biopsies will be taken from normal appearing colon mucosa
干预措施: colonic biopsies (Genetic)
patients having lower endoscopy
At least 2 weeks prior to scheduled lower endoscopy, consented study participants will be mailed a Brief Diet and Lifestyle Questionnaire, a stool collection kit with detailed instructions and a Stool Collection Data Sheet. No more than one week prior to the lower endoscopy but prior to initiation of bowel preparation, the consented participants will provide a stool specimen and fill out the two questionnaires. The routine lower endoscopy will be performed according to routine clinical procedures. Clinical biopsies of suspicious areas and/or lesions will be taken as per standard clinical care with all such tissue samples sent to pathology for routine clinical analysis. For the sole purposes of research, at the routine lower endoscopy, up to 8 additional colonic biopsies will be taken from normal appearing colon mucosa
干预措施: questionnaires (Genetic)
结局指标
主要结局
association of the gut microbiome and dietary factors (To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses)
时间窗: 2 years
with risk of adenoma or cancer in Lynch syndrome and other hereditary colonic polyposis syndrome patients. To validate said associations, individual questions from the Brief Diet and Lifestyle Questionnaire will be primarily used in the overall analyses.
次要结局
未报告次要终点