Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- Detection of tissue of origin signal in the cancer cohort
研究概览
简要总结
ClearNote Health is developing a test from whole blood for the early detection of multiple cancers. The goal of this study is to employ genomics, epigenomics and proteomics methodology for the detection of cancer signal in the blood of subjects with solid tumors.
详细描述
Epigenomic changes in cancer cells can provide a rich source of biomarker signals for the detection of disease. As cancer cells manifest their epigenomic changes in blood due to cell death, DNA and protein molecules can be probed using specific molecular analytic approaches. ClearNote Health employs epigenomic technologies to measure dynamic changes in DNA demethylation events via direct measurement of 5-hydroxymethyl-cytosine residues in cfDNA. Companion assays are also run to provide information on cfDNA digestion patterns and protein-based changes in plasma. This information, combined in a machine learning framework, enable the provision of prediction models that report on the presence of cancer and the determination of the tissue of tumor origin. This study will build predictive models and test performance of these models to detect the presence of cancer and tissue of origin in several cancer type by using a matched case-control study design.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be between 21-80 years of age at the time of enrollment
- •Patient fully consented
- •Cancer diagnosis OR high clinical suspicion for cancer, based on the participating site's and practitioner's standards of care (SOC)
- •No previous history of cancer and treatment naïve at time of enrollment
排除标准
- •Age < 21 OR > 80 years of age
- •Any prior cancer diagnosis with or without treatment (with the exception of non-melanoma skin cancers resolved/treated > 1 year prior to enrollment)
- •Receipt of any cancer therapy including chemotherapy, radiation, palliative radiation, hormonal or naturopathic therapies
- •In situ carcinoma without an invasive component
- •Any surgery requiring general anesthesia within 2 months of collection. Anesthesia used in procedures such as colonoscopy and EBUS is acceptable.
- •Receipt of systemic immunomodulation therapy within past 12 months
- •Currently pregnant, or pregnancy within last 12 months
- •Organ transplantation
- •Received dialysis
- •Blood transfusion within 1 month
- •Known HIV/AIDs, Hepatitis A, D, or E, TB, any kind of prion disorder (e.g., CJD) or other infectious pathogens currently present or present in past 5 years.
研究组 & 干预措施
Non-cancer
10,000 asymptomatic individuals without prior history of cancer
干预措施: Blood Draw (Other)
Cancer
10,000 individuals with confirmed malignancy
干预措施: Blood Draw (Other)
结局指标
主要结局
Detection of tissue of origin signal in the cancer cohort
时间窗: 1 year
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals from non-cancer controls
Detection of cancer signal in the cancer cohort
时间窗: 1 year
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals in plasma from non-cancer controls
Detection of cancer signal in the cancer cohort
时间窗: Baseline
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals in plasma from non-cancer controls
Detection of tissue of origin signal in the cancer cohort
时间窗: Baseline
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals from non-cancer controls
次要结局
未报告次要终点