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临床试验/NCT04191226
NCT04191226Unknown不适用

Overall Perspective on the Characteristics of Genetic Mutation in Recurrent Cervical Cancer

Lei Li1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年12月19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
Frequency of genetic mutations

研究概览

简要总结

Little is known about the characteristics of genetic mutation in recurrent cervical cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy and immunotherapy.

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

  • Aged 18 years or older
  • Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma
  • With available materials for analysis
  • With detailed clinicopathological information
  • Given consent to participate the trial

排除标准

  • Not meeting all of the inclusion criteria

结局指标

主要结局

Frequency of genetic mutations

时间窗: Two years

Frequency of various genetic mutations among recruited patients

次要结局

  • Frequency of microsatellite Instability(Two years)
  • Total mutation burden(Two years)
  • Expression rates of PD-1 and PD-L1 antibodies(Two years)

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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