Genetic analysis and development of liquid biopsy tests for early detection and treatment monitoring of cervical cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1. The primary outcome is to measure the percentage of cervical cancers that can be detected using a liquid biopsy. Samples from follow up timepoints will be useful for analysis of treatment and their prognostic value for success of brachytherapy.
研究概览
简要总结
The current study aims to test if a digital PCR based assay for detection of HPV in circulating tumor DNA (ctDNA) is a sensitive and a sustainable tool for early detection of CIN2 and CIN3 cervical cancer. Treatment monitoring and detection of minimal residual disease in more invasive HPV associated cancers.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Inclusion criteria includes Patients 18 years old or older with suspicion of cervical cancer referred to Manipal Comprehensive Cancer Center.
排除标准
- •Patients diagnosed with inflammatory or haematological disease after the age of 18 will be excluded from the study.
结局指标
主要结局
1. The primary outcome is to measure the percentage of cervical cancers that can be detected using a liquid biopsy. Samples from follow up timepoints will be useful for analysis of treatment and their prognostic value for success of brachytherapy.
时间窗: 0, 3, 6 months. Follow up at 36 months.
2.Measure recurrence in cervical cancer patients through serial monitoring with liquid biopsies (blood sample).
时间窗: 0, 3, 6 months. Follow up at 36 months.
3.Identification of novel cervical cancer susceptible genes or genetic markers in the Indian population.
时间窗: 0, 3, 6 months. Follow up at 36 months.
次要结局
- Identification of novel cervical cancer susceptible genes or genetic markers in the Indian population.(Pretreatment sample)