Predicting lymph node metastasis in advanced cervical cancer

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

This study is testing a new prediction tool to see if it can help doctors identify lymph node spread in patients with advanced cervical cancer who haven't had surgery or chemotherapy yet.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Chongqing University Cancer Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chongqing)
• Trial ID: NCT06068387 on ClinicalTrials.gov

What this trial studies

This prospective trial aims to evaluate the accuracy and feasibility of a prediction model for para-aortic lymph node metastasis in patients with locally advanced cervical cancer. It will assess whether this model can influence patient prognosis. Participants will undergo surgical staging to gather data for the model. The study focuses on patients who have not received prior surgical or chemotherapy treatments.

Who should consider this trial

Good fit: Ideal candidates include patients with FIGO stage Ib3 IIA2-IVA locally advanced cervical cancer who have not undergone prior surgical or chemotherapy treatments.

Not a fit: Patients with a history of immune diseases requiring immunosuppressive drugs or those with other malignancies diagnosed within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve prognostic accuracy and treatment planning for patients with locally advanced cervical cancer.

How similar studies have performed: While there may be studies on lymph node metastasis in other cancers, this specific prediction model for para-aortic lymph nodes in cervical cancer is novel and untested.

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.
* 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.

Where this trial is running

Chongqing

• Chongqing University Cancer Hospital — Chongqing, China (RECRUITING)

Study contacts

• Study coordinator: Dongling Zou, M.D.

Conditions: Locally Advanced Cervical Cancer