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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
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07029659
Enrollment
336
Registered
2025-06-19
Start date
2025-07-01
Completion date
2026-12-31
Last updated
2025-06-19

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

Conditions

Endometriosis, Endometriosis-Associated Ovarian Carcinoma

Keywords

Endometriosis, EAOC, OCS score

Brief summary

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.

Interventions

DIAGNOSTIC_TESTOvarian 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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The diagnostic performance of OCS in distinguishing EAOC from benign endometriotic lesions, including sensitivity and specificity.Preoperative blood draw.

Secondary

MeasureTime frame
The diagnostic performance of OCS for early-stage EAOC; its performance in differentiating various types of endometriosis and distinguishing EAOC subtypes.Preoperative blood draw.

Countries

China

Contacts

Primary ContactPeng Peng Associate Professor
pengp1999@163.com8613521361934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026