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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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Prospectively enroll patients with endometriosis and EAOC who complete the routine diagnostic and treatment process and consent to surgical intervention for OCS testing. Using postoperative ovarian pathological diagnosis as the gold standard, evaluate the clinical diagnostic performance of exosome detection in differentiating between endometriosis and EAOC.

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Detailed Description

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Conditions

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Endometriosis Endometriosis-Associated Ovarian Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Ovarian Cancer Score

Preoperatively, 5 ml blood samples were collected for OCS testing to determine the benign or malignant nature of ovarian endometriotic tissues. The OCS results were statistically analyzed against the gold standard of histopathological diagnosis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* (1) Females aged ≥18 years; (2) Initial 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

* (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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No