跳至主要内容
临床试验/NCT05685524
NCT05685524招募中不适用

Development of Diagnostic Model for Multi-cancer Diagnosis Based on DNA Methylation Biomarkers

Wuhan Ammunition Life-tech Co., Ltd1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Sensitivity

研究概览

简要总结

We intend to establish an efficient method for plasma cfDNA extraction and Bisulfite transformation to facilitate the detection of DNA methylation status using multiplex fluorescence PCR. Meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. Finally, we will provide a pan-cancer blood test that is easy to operate, low cost, accurate and easy to promote.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1)age >= 18 years. (2) with high suspicion of cancer diagnosed by endoscopy, other imaging examinations, pathological examinations, etc.
  • (3) no treatment with radiotherapy or chemotherapy.

排除标准

  • (1) received antineoplastic treatment such as radiation/chemotherapy. (2) not preserved as required. (3) contaminated or volume is insufficient. (4) unclear pathological results (5) incomplete patient information.

结局指标

主要结局

Sensitivity

时间窗: immediately after the procedure

The reference standard is the results of histopathological tests

Specificity

时间窗: immediately after the procedure

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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