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A Study Evaluating the Diagnostic Performance of OCS in the Differential Diagnosis of Endometriosis vs Endometriosis-Associated Ovarian Cancer

A Study Evaluating the Diagnostic Performance of OCS in the Differential Diagnosis of Endometriosis vs Endometriosis-Associated Ovarian Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104223
Enrollment
Unknown
Registered
2025-06-12
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Endometriosis and Endometriosis-Associated Ovarian Carcinoma

Interventions

Gold Standard:Pathological Diagnosis
Index test:In this study, the "Exosomal Ovarian Cancer Auxiliary Diagnostic Kit (Chemiluminescence Method)" (OCS) kit was used for sample detection

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Females aged >=18 years; 2. Nitial diagnosis of endometriosis or EAOC based on clinical presentation and imaging findings (including transvaginal ultrasound and MRI), with surgical indications; 3. Consent to surgical treatment and availability of postoperative ovarian pathological diagnosis; 4. Sufficient specimens for serum marker testing; 5. Voluntary participation in this study with signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women;?; 2. Patients who have previously undergone surgery with available ovarian histopathological examination results;?; 3. Confirmed cases of recurrent ovarian carcinoma;?; 4. Patients receiving chemotherapy or pelvic radiotherapy within 6 months prior to sample collection;?; 5. Concurrent primary malignancies;?; 6. Contraindications to surgical evaluation or inability to obtain ovarian surgical pathology information;?; 7. Specimens non-conforming to collection/preservation requirements, or contaminated/suspected contaminated samples.?;

Design outcomes

Primary

MeasureTime frame
Ovarian Cancer Score;OCS differentiates the performance of EAOC from benign masses in endometriosis;

Secondary

MeasureTime frame
OCS diagnoses performance in early EAOC;OCS differentiates between different types of endometrium Performance of heterotopia and different types of EAOC;

Countries

China

Contacts

Public ContactYang Xiang

Peking Union Medical College Hospital

xiangy@Pumch.cn+86 10 69155635

Outcome results

None listed

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