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

Locally Advanced Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06068387
• Other study ID #: CQGOG0109
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: October 2023
• Source: Chongqing University Cancer Hospital
• Contact: Dongling Zou, M.D.
• Phone: 13657690699
• Email: cqzl_zdl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Lymphatic Metastasis
• Uterine Cervical Neoplasms

Intervention

Procedure:
• surgical staging
para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy

Locations

Country	Name	City	State
China	Chongqing University Cancer Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing University Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of the prediction model	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	PFS	Progression-free Survival	3 years
Secondary	LRR	The local recurrence rate of para-aortic lymphatic drainage area	1 year
Secondary	LRR	The local recurrence rate of para-aortic lymphatic drainage area	2 year