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

Chongqing University Cancer Hospital

Status

Enrolling

Conditions

Locally Advanced Cervical Cancer

Treatments

Procedure: surgical staging

Study type

Interventional

Funder types

Other

Identifiers

NCT06068387

CQGOG0109

Details and patient eligibility

About

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.

Enrollment

264 estimated 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.
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.