Predictors of Para-aortic Lymph Node Metastasis of Cervical Cancer

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

COMPLETED

Total Enrollment

452 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-13

Study Completion Date

2022-12-12

Brief Summary

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The goal of this observational study is to identify predictive factors and to develop a risk model predicting para-aortic lymph node metastasis in patients with locally advanced cervical cancer based on the analysis of surgical staging results. The main questions it aims to answer are:

* What are the risk factors to predict para-aortic lymph node metastasis in patients with locally advanced cervical cancer?
* What is the indication for prophylactic extended-field radiation therapy in patients with locally advanced cervical cancer Individual data of patients with locally advanced cervical cancer treated with surgical staging at our institution from 2020 to 2022 were pooled analysed.Multivariate Logistic regression analysis was used to identify the predictive factors and to develop the prediction model.

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Detailed Description

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Individual data of 336 patients with locally advanced cervical cancer treated with surgical staging at our institution from January 2020 to August 2022 were pooled analysed. The following factors were collected from each patient to identify variables predicting para-aortic lymph node metastasis: age, T-staging，histopathological type，tumor size, differentiation, pretreatment tumor markers (squamous carcinoma antigen, carcinoembryonic antigen, Carbohydrate antigen 125 and cytokeratin fragment 21-1 , human papilloma virus type, the status of pelvic lymph node on images, common iliac lymph node and the short-axis diameter of the largest positive and the status of para-aortic lymph node on surgical staging results. Multivariate Logistic regression analysis was used to develop the prediction model. A simplified scoring system for each independent predictive factors was developed according to its coefficient. Internal validation was performed to assess the model. An independent validation cohort contained 116 patients with the same criteria from March 2018 to December 2019.

Conditions

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Locally Advanced Cervical Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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experimental group

locally advanced cervical cancer treated with surgical staging

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.
* Abdominal pelvic CT, MRI or PET/CT were performed before treatment.
* Patients with successful surgical staging and the pathological data of para-aortic lymph node were obtained.

Exclusion Criteria

* Patients were excluded if the histopathological type was not squamous cell carcinoma or Adenocarcinoma, and the data of LN status was not available.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No