Clinical trial NCT05717751: Predictors of Para-aortic Lymph Node Metastasis of Cervical Cancer
Official title: Predictors of Para-aortic Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer Based on the Pooled Analysis of Surgical Staging Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 452
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The primary cohort of this study comprised an evaluation of the institutional database for medical records from January 2020 to August 2022 to identify patients with locally advanced cervical cancer who underwent surgical staging.

From March 2018 to December 2019, an independent validation cohort of 116 consecutive patients was screened using the same criteria as that for the primary cohort.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Predictors of para-aortic lymph node metastasis
timeFrame: 3 months
measure: The prediction model of para-aortic lymph node metastasis
timeFrame: 3 months
Secondary outcomes:
measure: validation of the prediction model
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Dongling Zou, M.D.
role: STUDY_DIRECTOR
References: