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

October 5, 2023 updated by: Dongling Zou, Chongqing University Cancer Hospital

A Prospective Study on the Application of Para-aortic Lymph Node Metastasis Prediction Model in Locally Advanced Cervical Cancer and Its Effect on Prognosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
locally advanced cervical cancer treated with surgical staging
Procedure: surgical staging
para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of the prediction model
Time Frame: 2 years
The performance of the model was assessed with respect to discrimination which was measured by the concordance index and calibration which was assessed by the calibration curve, Hosmer-Lemeshow test and Brier score. The investigators will calculate respectively the sensitivity and 95% confidence interval (CI), specificity and 95% CI, positive likelihood ratios (LR+) and 95% CI, negative likelihood ratios (LR-) and 95% CI, and the Kappa value.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 3 years
Progression-free Survival
3 years
LRR
Time Frame: 1 year
The local recurrence rate of para-aortic lymphatic drainage area
1 year
LRR
Time Frame: 2 year
The local recurrence rate of para-aortic lymphatic drainage area
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing University Cancer Hospital

Investigators

  • Study Director: Dongling Zou, M.D., Chongqing University Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQGOG0109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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