Predictors of Para-aortic Lymph Node Metastasis of Cervical Cancer

NCT05717751 | Completed

• 1 other identifier: CQGOG0110
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• Predictors of para-aortic lymph node metastasis

  We evaluate the institutional database for medical records to identify patients who underwent surgical staging, then comprised the primary and the independent validation cohort, respectively. The variables were collected from each patient. We assess the bivariate relationship between each variable and para-aortic lymph node metastasis via logistic regression analysis. The potential predictive variables of a P-value\<0.05 on univariate analysis were considered as risk factors.

  3 months

• The prediction model of para-aortic lymph node metastasis

  The multivariable logistic regression analysis between predictors and para-aortic lymph node metastasis was conducted and evaluated odds ratio. To facilitate practical application, a score chart was developed to present the final prediction model. The risk score of predictive variables were calculated and rounded based on its beta-coefficients from the multivariate logistic regression analysis. The prediction model was then developed by combining all scores, and the sum of scores for each predictor represented the risk score for every patient.

  3 months

Secondary Outcomes (1)

• validation of the prediction model

  3 months

Study Arms (1)

experimental group

locally advanced cervical cancer treated with surgical staging

Procedure: surgical staging

Interventions

surgical staging PROCEDURE

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

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Study Officials

• Dongling Zou, M.D.

  Chongqing University Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Director

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 8, 2023
• Study Start: April 13, 2022
• Primary Completion: November 12, 2022
• Study Completion: December 12, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

CN (1)