The Implication of Plasma Circulating Tumor DNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas: a Multicenter, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,138
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
This is a multicenter, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.
详细描述
Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, multicenter, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.
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
- 是
入选标准
- •Healthy Individuals:
- •Written informed consent must be obtained from healthy individuals to comply with the requirements of the study.
- •Healthy individuals who received colonoscopy.
- •Patients with Colorectal Cancer or Adenomas:
- •Male or female ≥ 18 years of age on the day of signing informed consent.
- •Patients need to receive surgical resection or endoscopic resection.
- •Patients must have histologically confirmed stage I-IV colorectal cancer or adenomas
- •Patients must have a performance status of ≤1 on the ECOG Performance Scale.
- •Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
排除标准
- •Patients received adjuvant treatment prior to the surgical resection.
- •Patients received blood transfusion two weeks before or during the surgical resection.
- •Patients with unresected advanced colorectal adenoma.
- •Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
- •Patients who are pregnant.
- •Patients who are alcoholic or drug abusers.
- •Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.
结局指标
主要结局
Sensitivity
时间窗: 2 years
The sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer and adenoma
Specificity
时间窗: 2 years
The specificity of plasma ctDNA methylation haplotypes in healthy individuals
次要结局
未报告次要终点