A Prognostic Research on First-Line Recurrent and Metastatic Cervical Cancer Using Circulating Cell-Free DNA and Human Papillomavirus Detection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
Primary Objective of this study: To investigate the correlation between longitudinal quantitative dynamics of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA) in peripheral blood and clinical prognosis among patients with recurrent and metastatic cervical cancer who achieved complete response following standard first-line systemic therapy.
详细描述
This study plans to enroll patients with recurrent and metastatic cervical cancer who attain complete response after standard first-line systemic therapy. A total of 20 mL peripheral blood will be collected from each subject every 3 months over a planned one-year period (5 sampling time points in total). Plasma separated from blood samples will be subjected to quantitative detection and comparative analysis of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA). Tumor tissue specimens (5-10 unstained paraffin sections) will also be collected from patients at the time of recurrent disease confirmation. It is estimated that 60 patients will be recruited and followed up dynamically for 3 years to observe clinical prognosis. This is a prospective, observational single-center cohort study. Peripheral blood samples will only be collected at scheduled time points to explore novel biomarkers associated with disease recurrence.
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
- 否
入选标准
- •Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
- •Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease);
- •Received standard first-line therapy (TP/TC regimen plus immunotherapy ± bevacizumab);
- •Achieved complete response (CR) following standard first-line treatment;
- •Archived pathological biopsy specimens of recurrent/metastatic lesions prior to treatment available in our hospital;
- •Participated in clinical trials of pharmaceutical therapy for first-line recurrent/metastatic cervical cancer conducted at our institution;
- •Voluntarily participates in this study and provides written informed consent;
- •Agrees to serial peripheral blood collection at scheduled time points;
- •Willing to complete scheduled follow-up visits;
- •Aged ≥ 18 years old.
排除标准
- •History of other malignant tumors within the past 2 years;
- •Pregnant or breastfeeding women;
- •Severe concomitant diseases, including: cardiovascular diseases (e.g., uncontrolled heart failure, unstable angina, etc.); pulmonary diseases (e.g., severe chronic obstructive pulmonary disease, interstitial pneumonia and other conditions impairing respiratory function); hepatic and renal dysfunction (e.g., decompensated liver cirrhosis, severe renal failure requiring dialysis, etc.);
- •Refusal to sign informed consent;
- •Refusal to undergo serial blood collection.
研究组 & 干预措施
Recurrent metastatic cervical cancer with complete response
Patients with recurrent and metastatic cervical cancer who achieved complete response after standard first-line systemic therapy.
干预措施: Biospecimen collection (peripheral blood and paraffin tumor tissue) (Diagnostic Test)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: Up to 3 years after patient enrollment.
Time from enrollment to confirmation of disease recurrence or death from any cause, whichever occurs first, assessed over a 3-year follow-up period.
次要结局
- Dynamic changes of tumor ctDNA and HPV cfDNA to predict residual disease and tumor recurrence(Up to 3 years after enrollment)
- Overall Survival (OS)(Up to 3 years after enrollment)
研究者
Tao Zhu
Professor
Zhejiang Cancer Hospital