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Trial Title:
A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis
NCT ID:
NCT06068387
Condition:
Locally Advanced Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Lymphatic Metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
surgical staging
Description:
para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta
caudally via laparoscopy or laparotomy
Arm group label:
experimental group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Qi, M.D.
Phone:
13036399093
Email:
kjb65310859@163.com
Start date:
March 1, 2023
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Source:
Chongqing University Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06068387
