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AI-Assisted Screening and Diagnosis of Endometrial Lesions Based on Multi-Modal Data

AI-Assisted Screening and Diagnosis of Endometrial Lesions Based on Multi-Modal Data

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101707
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-05-06
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

Endometrial hyperplasia without atypia?Endometrial hyperplasia with atypia?Endometrial cancer

Interventions

Index test:Methylation Testing ?Liquid-Based Cytology?minimal tissue specimens

Sponsors

Second Xiangya Hospital of CSU
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients presenting with irregular vaginal bleeding; 2.Individuals with increased risk factors (meeting >=1 of the following criteria AND concurrent endometrial thickening): (1) Obesity (body mass index, BMI >=30 kg/m²); (2) Polycystic ovary syndrome (PCOS); (3) History of unopposed estrogen therapy (without progesterone antagonism); (4) Late menopause (>55 years old); (5) Nulliparity or primary infertility; (6) Long-term tamoxifen therapy (especially in patients >50 years old or postmenopausal); (7) Age >=45 years with concurrent diabetes mellitus. Endometrial thickening criteria: Premenopausal women: endometrial thickness >=11 mm; Postmenopausal women: endometrial thickness >=5 mm; 3.High-risk populations: Lynch syndrome carriers and their first-degree relatives, screened annually after 30–35 years of age (or 5–10 years before the earliest cancer diagnosis age in affected family members).

Exclusion criteria

Exclusion criteria: 1.Patients during menstruation, pregnancy, or lactation; 2.Patients who have undergone hormonal therapy within the past 3 months; 3.Patients with concurrent malignancies or autoimmune diseases; 4.Patients with psychiatric disorders or inability to comply with the study protocol; 5.Patients with an intrauterine device (IUD) in situ; 6.Patients with a history of recent intrauterine procedures (within 1 month), including: Uterine curettage, Endometrial biopsy, IUD insertion/removal, Other endometrial trauma; 7.Incomplete medical records or unavailable pathological imaging data.

Design outcomes

Primary

MeasureTime frame
Pathology results of minimal tissue specimens;

Secondary

MeasureTime frame
Methylation Testing;

Countries

China

Contacts

Public ContactFu Chun

The Second Xiangya Hospital of Central South University

fuchun0814@csu.edu.cn+86 731 85292476

Outcome results

None listed

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