A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis

Conditions
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Locally Advanced Cervical Cancer

Intervention / Treatment
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* Procedure: surgical staging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>locally advanced cervical cancer treated with surgical staging | Procedure: surgical staging<br>* para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free Survival | 3 years | 
| LRR | The local recurrence rate of para-aortic lymphatic drainage area | 1 year | 
| LRR | The local recurrence rate of para-aortic lymphatic drainage area | 2 year |