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Predictors of Para-aortic Lymph Node Metastasis of Cervical Cancer

C

Chongqing University Cancer Hospital

Status

Completed

Conditions

Locally Advanced Cervical Cancer

Treatments

Procedure: surgical staging

Study type

Observational

Funder types

Other

Identifiers

NCT05717751
CQGOG0110

Details and patient eligibility

About

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.

Full description

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.

Enrollment

452 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

452 participants in 1 patient group

experimental group
Description:
locally advanced cervical cancer treated with surgical staging
Treatment:
Procedure: surgical staging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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