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Development and Validation of an Intelligent Diagnostic Model for Endometrial Cancer Based on Multimodal Data

Development and Validation of an Intelligent Diagnostic Model for Endometrial Cancer Based on Multimodal Data

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120511
Enrollment
Unknown
Registered
2026-03-16
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Endometrial Cancer

Interventions

Observation group:None

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients meeting the criteria for high-risk or increased-risk populations: According to the 2020 Recommendations for Endometrial Cancer Screening, patients are considered to be at high risk or increased risk if they have at least one of the following conditions: (1)Obesity, defined as body mass index (BMI) >=30 kg/m²; (2)Polycystic ovary syndrome (PCOS); (3)Use of estrogen without progestin opposition; (4)Late menopause (>55 years); (5)Nulliparity or primary infertility; (6)Long-term tamoxifen use, especially in patients older than 50 years or those who continue tamoxifen after menopause; (7)Age>= 45 years with diabetes mellitus; (8)Lynch syndrome; having a first-degree relative with Lynch syndrome without relevant genetic testing; or a personal or family history of colorectal cancer. 2.Underwent endometrial cytology examination, with retained cytology slides of qualified quality and complete staining; 3. Had a definite histopathological diagnosis that could serve as the gold standard for cytological interpretation; 4. The interval between endometrial cytology sampling and histological sampling was <=14 days, and no intervention that might affect the endometrial status was performed during this period.

Exclusion criteria

Exclusion criteria: 1. Unqualified cytology samples, including but not limited to the following conditions: (1)Slides lacking clear identification labels or being severely damaged and irreparable; (2)Severe cell overlap, glandular cells obscured by blood or inflammatory cells, poor fixation, or excessive drying of the specimen; (3)Contamination or other factors resulting in >=75% of glandular cells being uninterpretable; 2.An interval of more than 14 days between cytological and histopathological sampling, or the presence of factors during this period that might interfere with the endometrial status, such as intrauterine procedures, hormonal or endocrine therapy, radiotherapy, chemotherapy, or targeted therapy; 3. Incomplete clinical or ultrasound information; 4. Any other conditions deemed unsuitable for inclusion in this study by the investigators.

Design outcomes

Primary

MeasureTime frame
Area under the receiver operating characteristic curve (AUC) of the multimodal intelligent diagnostic model for endometrial cancer;Area under the receiver operating characteristic curve (AUC) of the cytology-based intelligent diagnostic model for endometrial cancer;

Secondary

MeasureTime frame
Sensitivity and specificity of the multimodal intelligent diagnostic model;Agreement between model-based interpretation and expert cytological interpretation;

Countries

China

Contacts

Public ContactLei Zhang

Beijing Tsinghua Changgung Hospital

18601130459@163.com+86 186 0113 0459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026