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

Primary Purpose

Locally Advanced Cervical Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
surgical staging
Sponsored by
Chongqing University Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Locally Advanced Cervical Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Chongqing University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental group

Arm Description

locally advanced cervical cancer treated with surgical staging

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PFS
Progression-free Survival
LRR
The local recurrence rate of para-aortic lymphatic drainage area
LRR
The local recurrence rate of para-aortic lymphatic drainage area

Full Information

First Posted
September 14, 2023
Last Updated
October 5, 2023
Sponsor
Chongqing University Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06068387
Brief Title
A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing University Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
locally advanced cervical cancer treated with surgical staging
Intervention Type
Procedure
Intervention Name(s)
surgical staging
Intervention Description
para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy
Primary Outcome Measure Information:
Title
The accuracy of the prediction model
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free Survival
Time Frame
3 years
Title
LRR
Description
The local recurrence rate of para-aortic lymphatic drainage area
Time Frame
1 year
Title
LRR
Description
The local recurrence rate of para-aortic lymphatic drainage area
Time Frame
2 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongling Zou, M.D.
Phone
13657690699
Email
cqzl_zdl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongling Zou, M.D.
Organizational Affiliation
Chongqing University Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Qi, M.D.
Phone
13036399093
Email
kjb65310859@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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