Innovation for Standard Identification for Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cance: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV : Human PapillomaVirus)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
研究概览
简要总结
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
详细描述
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with cervical cancer, at any stage, before any anti-tumoral treatment.
- •Age ≥ 18 years.
- •Patient information and signature of the informed consent or her/his legal representative.
- •Patient having given her/his agreement for a second biopsy at diagnosis if the first one was performed outside of the center and was not cryopreserved.
排除标准
- •Person deprived of liberty or under supervision.
- •Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons.
结局指标
主要结局
Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.
时间窗: Until 2 years after treatment
Detection rate of circulating tumoral DNA with confidence interval of 95% of this rate. Description of the variability of this rate according to the initial stage of the disease, treatment and disease progression.
次要结局
- Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences.(Until 2 years after treatment)
- Detailed molecular characterization of genes alterations implicated in cervical oncogenesis.(Until 2 years after treatment)