NCT06537063撤回不适用
Early Diagnosis Value of G-quadruplex DNA Methylation in Patients with Cancer
Zhongnan Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- G-quadruplex DNAm score
研究概览
简要总结
This study aims to evaluate the early diagnosis value of G-quadruplex DNA methylation in patients with cancer.
详细描述
Global DNA hypomethylation is a hallmark of most cancers that occurs early during oncogenesis. We would like to investigate whether cancer-specific transcription factor binding to DNA G-quadruplex drives DNA hypomethylation in cancer. In this observational study, we would like to clarify whether DNA hypomethylation around G-quadruplex loci in cell-free DNA could be detected in early-stage cancer patients from healthy donors with high sensitivity and specificity.
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
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers identified as asymptomatic during medical examination;
- •Age≥42 years old;
- •Voluntarily participate in this study and sign the informed consent.
排除标准
- •History of malignancy or having achieved complete remission following tumor surgery;
- •Certain autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, antiphospholipid syndrome, rheumatoid arthritis, Crohn's disease, IgA nephropathy, myasthenia gravis, dermatomyositis, immune thrombocytopenic purpura, etc.);
- •Pregnancy;
- •Acute trauma (including surgical procedures), sudden onset organ failure (e.g., resulting from a car accident, fulminant hepatic failure, acute pancreatitis, severe pneumonia due to influenza virus), or diagnosis of sepsis;
- •Previous receipt of allogeneic blood transfusion, transplant surgery, or allogeneic cell therapy;
- •Volunteers who cannot provide informed consent.
结局指标
主要结局
G-quadruplex DNAm score
时间窗: 2024.04.30-2024.09.30
Detection of DNAm around G-quadruplex loci in cell-free DNA from blood.
次要结局
未报告次要终点
研究者
Yu Xiao
Director
Zhongnan Hospital
研究点 (1)
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