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

Not Applicable

Recruiting

• Conditions: Locally Advanced Cervical Cancer
• Interventions: Procedure: surgical staging

• Registration Number: NCT06068387
• Lead Sponsor: Chongqing University Cancer Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-28
• Status Verified: 2023-10
• Study First Posted: 2023-10-05
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10
• Primary Completion: 2025-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 264

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	surgical staging	locally advanced cervical cancer treated with surgical staging

Primary Outcome Measures

Name	Time	Method
The accuracy of the prediction model	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.

Secondary Outcome Measures

Name	Time	Method
PFS	3 years	Progression-free Survival
LRR	2 year	The local recurrence rate of para-aortic lymphatic drainage area

Trial Locations

Locations (1)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, China