Role of Genomic Imprinting in Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Specificity of imprinting cancer early detection
研究概览
简要总结
The current research focus for cancer diagonosis is classical genetics, named "driving genes". However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. The normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. This study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with suspicious cancer by ultrasound, CT or endoscope.
- •Biopsy samples available.
- •Male or female patients aged ≥ 18 years.
- •Participants signed informed consent form.
排除标准
- •Age under 18 years.
- •Severe cardiovascular diseases.
- •Central nervous system diseases.
- •Mental disorder.
- •Pregnant.
- •Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery.
结局指标
主要结局
Specificity of imprinting cancer early detection
时间窗: In the middle of the study, an average of 15 months
Number of patients "declared negative" with the imprinting early detection among the patients who are with benign tumors or other diseases
Sensitivity of imprinting cancer early detection
时间窗: In the middle of the study, an average of 15 months
Number of patients "declared positive" with the imprinting early detection among the patients suffered from cancer
次要结局
- Comparison of the sensitivity of the imprinting detection versus cytopathology(In the middle of the study, an average of 15 months)
- Comparison of the specificity of the imprinting detection versus cytopathology(In the middle of the study, an average of 15 months)
研究者
Bai Chunxue
Chair
Chinese Alliance Against Lung Cancer