Clinical trial · Observational
A Study Evaluating the Diagnostic Performance of OCS in the Differential Diagnosis of Endometriosis vs. Endometriosis-Associated Ovarian Cancer
NCT07029659CI-TRIAL-00091170not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometriosis | — | UNRESOLVED | — |
| Endometriosis-Associated Ovarian Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ovarian Cancer Score | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The diagnostic performance of OCS in distinguishing EAOC from benign endometriotic lesions, including sensitivity and specificity.
- timeFrame
- Preoperative blood draw.
Secondary outcomes (1)
- measure
- The diagnostic performance of OCS for early-stage EAOC; its performance in differentiating various types of endometriosis and distinguishing EAOC subtypes.
- timeFrame
- Preoperative blood draw.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.