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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06068387
Other study ID # CQGOG0109
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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