Status:

NOT_YET_RECRUITING

A Prospective Cohort Study Comparing AI Prediction Model With Imaging Assessment to Diagnose Lymph Node Metastasis in Cervical Cancer

Lead Sponsor:

Obstetrics & Gynecology Hospital of Fudan University

Conditions:

Uterine Cervical Neoplasms

Eligibility:

FEMALE

18-80 years

Phase:

NA

Brief Summary

The goal of this prospective cohort study is to learn whether artificial intelligence multimodal fusion prediction models are effective in diagnosing pelvic lymph node metastasis in cervical cancer. T...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • patients with preoperative diagnosis of invasive cervical cancer stage I-III, with any type of pathology, and patients who underwent radical/modified radical cervical cancer surgery + pelvic lymph node dissection in our hospital or sub-center;
  • Age ≥18 years and ≤80 years;
  • patients who underwent preoperative pelvic MRI (plain/enhanced) imaging in our hospital or sub-centers.
  • Exclusion criteria:
  • patients during pregnancy or lactation, patients with abortion within 42 days;
  • patients who are undergoing or have undergone preoperative neoadjuvant chemotherapy or radiotherapy for this cervical cancer;
  • Patients with other malignant tumors within 5 years;
  • Combination of other underlying diseases that may lead to enlarged pelvic lymph nodes;
  • patients whose preoperative pelvic MRI date is more than 1 month from the day of surgery;
  • poor quality imaging images that are unrecognizable.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2027

    Estimated Enrollment :

    230 Patients enrolled

    Trial Details

    Trial ID

    NCT06541288

    Start Date

    August 1 2024

    End Date

    December 1 2027

    Last Update

    August 7 2024

    Active Locations (1)

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    The Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, China, 200090