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A Prospective Single-Arm Exploratory Study on CT-Based Radiomics Combined with Clinical Parameters for Predicting Lymph Node Metastasis in Gynecological Malignancies (Cervical, Ovarian, Endometrial and Vulval Cancers)

A Prospective Single-Arm Exploratory Study on CT-Based Radiomics Combined with Clinical Parameters for Predicting Lymph Node Metastasis in Gynecological Malignancies (Cervical, Ovarian, Endometrial and Vulval Cancers)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113585
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Malignancies (Cervical, Ovarian, Endometrial and Vulval Cancers)

Interventions

Test group:Gynecological malignant tumors undergoing systematic lymph node resection during the operation

Sponsors

The Second Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients with gynecological malignant tumors (including cervical cancer, ovarian cancer, endometrial cancer and vulvar cancer) who underwent surgical treatment in our hospital; (2) Postoperative pathological diagnosis confirmed as cervical cancer, ovarian cancer, endometrial cancer or vulvar cancer, and lymph node resection was performed during the operation; (3) Complete clinical and pathological data and imaging examination data are available, and enhanced CT examination was conducted within 2 weeks before the operation; (4) The subjects voluntarily participated and signed the informed consent form; (5) According to the judgment of the researchers, there are no absolute surgical contraindications, the patients can tolerate surgical treatment, and they can comply with the trial protocol.

Exclusion criteria

Exclusion criteria: (1) Combined with other malignant tumors; (2) Incomplete clinical data; (3) Active or uncontrolled severe infections; (4) History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiencies; (5) Patients who cannot understand the experimental content and cannot cooperate, or those who refuse to sign the informed consent form; (6) Patients with serious accompanying diseases or other special circumstances that pose a threat to their safety or affect their ability to complete the study.

Design outcomes

Primary

MeasureTime frame
Lymph node metastasis situation;DICOM format file of enhanced CT images of the pelvic cavity;DICOM format file of enhanced MR images of the pelvic cavity;AUC-ROC;

Secondary

MeasureTime frame
pathological pattern;Pathological differentiation;pathological feature;clinical stages;tumor marker;blood routine examination;age;height;weight;Blood coagulation routine test;

Countries

China

Contacts

Public ContactShichao Han

the second affliated hospital of Dalian Medical University

hscsuperman@126.com+86 177 0987 2769

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026