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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-02-28

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.

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Detailed Description

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Conditions

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Locally Advanced Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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experimental group

locally advanced cervical cancer treated with surgical staging

Group Type EXPERIMENTAL

surgical staging

Intervention Type PROCEDURE

para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy

Interventions

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surgical staging

para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No