Use of Multiscale Omics to Develop a Cohort Database and Study Platform in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Utilization of multiscale omics to build a cohort database for breast cancer survivors
研究概览
简要总结
This study gathers information to create a database to improve the ability to diagnose cancer, predict long term health of breast cancer patients, and help develop future treatment products. This study will provide a foundational platform for therapeutic development and intervention studies in the future and may for therapeutic development and intervention studies in the future, and may advance researchers understanding of the contribution gut bacteria to altered circulating estrogens in breast cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To use multiscale omics to build a cohort database that can be used as a reference population in support of multivariate analysis, predictive modeling, and development of natural product therapeutics and precision medicine applications for breast cancer survivors.
SECONDARY OBJECTIVE:
I. To detect unique patterns of variance between 1) targeted serum metabolites, 2) plasma metabolome, 3) gut microbiome community structure, 4) gut microbiome metabolome, 5) urine metabolome, 6) quality of life measures, and 7) breast cancer survivors (BCS) symptoms by using multivariate analysis, machine learning tools, and artificial intelligence applied to the large data sets developed in this trial.
OUTLINE:
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BCS GROUP
- •Female patients diagnosed with breast cancer age 18 - 75, stages 0 through 3 at time of diagnosis
- •Who have completed active therapy (including surgery, radiation, and/or chemotherapy)
- •Able to speak English and complete surveys and provide the specimen (willing to follow the sample collection instructions)
- •Able to read, understand and sign inform consent
- •CONTROL GROUP
- •Healthy Volunteers age 18 - 75
- •Able to speak and read English, complete consent, surveys, and provide specimens
排除标准
- •Unable to give written consent
- •Unable to fast before providing blood and urine
- •Pregnant women (per participant report) and males
- •Unwilling to travel to Mayo Clinic Rochester to provide bio specimens
结局指标
主要结局
Utilization of multiscale omics to build a cohort database for breast cancer survivors
时间窗: Up to 5 years
次要结局
- Detection of unique patterns of variance(Up to 5 years)