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临床试验/NCT05310357
NCT05310357Unknown不适用

The Role of Chromosomal Instability in Monitoring the Course of Ovarian High-grade Serous Carcinoma

Lei Li1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Incidence of chromosomal instability (CIN)

研究概览

简要总结

Chromosomal instability (CIN) refers to the ongoing genomic change, which involves the amplification or deletion of chromosome copy number or structure. The changes rang from point mutation to small-scale genomic change and even the change of whole chromosome number. It has been reported that the characteristics of genomic rearrangement can be used as a marker of clinical outcome of high-grade serous ovarian cancer, and specific genomic rearrangement are related to the poor prognosis. In noninvasive gene detection with low coverage, patients diagnosed with ovarian cancer have deteriorating progression-free and overall survivals regardless of the tumor stage when somatic copy number distortion (sCNA) exceeds the threshold in plasma. The detection rate of sCNA increased along with the tumor stage. We enrolled those as our target patients, who are diagnosed with high-grade serous ovarian cancer and willing to take part in. The CIN in peripheral cell-free DNA was observed before initial treatment, after primary debulking or staging surgeries, before recurrence and during the process of recurrence treatment. Our aim is to explore the application of CIN in peripheral tumor DNA in the detection of minimal residual lesions (MRD) after primary treatment and recurrence monitoring.

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
Female
接受健康志愿者

入选标准

  • Confirmed of primary ovarian high grade serous carcinoma (HGSC)
  • Aged 18 years or older
  • Acceptance of surgical treatment for HGSC
  • With detailed follow-up outcomes

排除标准

  • Not meeting all of the inclusion criteria
  • Declining to anticipate the trial

结局指标

主要结局

Incidence of chromosomal instability (CIN)

时间窗: One year

Incidence of chromosomal instability tested in peripheral cell-free DNA

次要结局

  • Progression-free survival(One year)
  • Overall survival(One year)

研究者

发起方
Lei Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Li

Professor

Peking Union Medical College Hospital

研究点 (1)

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