Locally Advanced Cervical Cancer Clinical Trial
Official title:
A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis
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.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | February 28, 2026 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 ~ 1. - The expected survival time>6 months; - There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Chongqing University Cancer Hospital | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Chongqing University Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The accuracy of the prediction model | 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. | 2 years | |
Secondary | PFS | Progression-free Survival | 3 years | |
Secondary | LRR | The local recurrence rate of para-aortic lymphatic drainage area | 1 year | |
Secondary | LRR | The local recurrence rate of para-aortic lymphatic drainage area | 2 year |
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