Clinical Trials on Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
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
- DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate cancer
研究概览
简要总结
Prostate cancer is a leading cause of mortality and morbidity.
The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in prostate cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff
排除标准
- •Pregnant women
- •Minors (subjects less than 18 years of age)
- •Prisoners
- •Patients having other than one cancer
- •Subjects unable to consent for themselves
- •Symptomatic of acute prostatitis
结局指标
主要结局
DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate cancer
时间窗: 6 months to 1 year
We will develop the linear model and a threshold value differentiating breast cancer from control based on the 100 patient training set. The model will be provided to the researchers: Methylation score=CG1\*b1+CG2\*b2+ CG3\*b3 + e CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept. We will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. We will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as prostate cancer or not.
次要结局
未报告次要终点