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RecruitingNCT06448897Updated Jun 7, 2024

Development of an Imaging Prediction Model for Pelvic Lymph Node Metastasis of Cervical Cancer Using Artificial Intelligence Techniques.

An observational study in Cervical Cancer, Lymph Node Metastasis and Artificial Intelligence, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
4,000
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

This study is a retrospective exploratory trial conducted at a single center, aiming to develop and validate a preoperative lymphatic metastasis model for cervical cancer using artificial intelligence deep learning. The model is trained using preoperative imaging and postoperative pathological findings of cervical cancer patients, with the goal of enhancing the accuracy of lymphatic metastasis prediction through preoperative imaging and offering insights for treatment decisions.

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Conditions studied

  • Cervical Cancer
  • Lymph Node Metastasis
  • Artificial Intelligence

Keywords

  • Cervical Cancer
  • Lymph Node Metastasis
  • Artificial Interlligence
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University is the lead sponsor of 23 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patient information and imaging data were collected from the Obstetrics and Gynecology Hospital of Fudan University. This hospital is a specialized tertiary care facility and is recognized as the leading Obstetrics and Gynecology hospital in China.

Inclusion criteria

  1. 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.
  2. Age ≥18 years old and ≤80 years old
  3. patients with complete preoperative pelvic MRI images and postoperative pathology and clinical data in our hospital

Exclusion criteria

Exclusion criteria:

  1. Patients during pregnancy or breastfeeding, patients within 42 days of abortion
  2. Patients who have received neoadjuvant chemotherapy or radiotherapy before surgery for this previous cervical cancer
  3. Patients with other malignant tumors within 5 years
  4. Combination of other underlying diseases that may lead to enlarged pelvic lymph nodes
  5. Imaging report more than 1 month prior to surgery
  6. Poor image quality and unrecognizable
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
4,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. A model for identifying pelvic lymph node metastases on preoperative imaging

    Artificial intelligence (AI) technology was utilized to develop a model for identifying pelvic lymph node metastasis from preoperative images in order to enhance the accuracy of preoperative lymph node metastasis detection in cervical cancer. The model was validated with the main diagnostic focus on determining the status of lymph node metastasis.

    Time frame: From enrollment to the end of development of model at 24 months

07

Study locations

1 of 1 sites recruiting
  • The Obstetrics and Gynecology Hospital of Fudan University
    Shanghai, Shanghai 200090, China
    • Xin Wu · Contact · wuxin_fc@fudan.edu.cn · 8613764046908
    • Xin Wu · Principal investigator
    • Hua Jiang · Sub investigator
    • Xuan Yin · Sub investigator
    • Ling Qiu · Sub investigator
    • Hui Wang · Sub investigator
    • Yang Liu · Sub investigator
    • Shen Luo · Sub investigator
    • Xiaomei Sun · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06448897
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Responsible party
Sponsor
First posted
Jun 7, 2024
Start date
Feb 1, 2024
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jun 7, 2024

Study contacts

Xin Wu
Contact
wuxin_fc@fudan.edu.cn
(021)33189900

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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