A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- The accuracy of the prediction model
研究概览
简要总结
The goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. The main questions it aims to answer are:
- Is the para-aortic lymph node metastasis prediction model accurate and feasible?
- Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA;
- •It was treated initially without surgical and chemotherapy.
- •Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology.
- •Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment.
- •ECOG score:0 ~
- •The expected survival time>6 months;
- •There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance.
排除标准
- •History of immune disease who need to take immunosuppressive drugs.
- •History of serious mental illness and brain functional disorder.
- •Other malignancies were diagnosed within five years or needed treatments.
- •Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
- •Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians.
- •Patients who cannot understand the research regimen and refuse to sign the informed consent form.
- •Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
结局指标
主要结局
The accuracy of the prediction model
时间窗: 2 years
The performance of the model was assessed with respect to discrimination which was measured by the concordance index and calibration which was assessed by the calibration curve, Hosmer-Lemeshow test and Brier score. The investigators will calculate respectively the sensitivity and 95% confidence interval (CI), specificity and 95% CI, positive likelihood ratios (LR+) and 95% CI, negative likelihood ratios (LR-) and 95% CI, and the Kappa value.
次要结局
- PFS(3 years)
- LRR(2 year)
研究者
Dongling Zou
Director
Chongqing University Cancer Hospital