Not yet recruiting NCT07029659
A Study Evaluating the Diagnostic Performance of OCS in the Differential Diagnosis of Endometriosis vs. Endometriosis-Associated Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ovarian Cancer Score.
- Who it may be relevant to
- Registry conditions: Endometriosis, Endometriosis-Associated Ovarian Carcinoma. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test 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.
Primary outcome measures
- The diagnostic performance of OCS in distinguishing EAOC from benign endometriotic lesions, including sensitivity and specificity. [Time frame: Preoperative blood draw.]
Secondary outcome measures (1)
- The diagnostic performance of OCS for early-stage EAOC; its performance in differentiating various types of endometriosis and distinguishing EAOC subtypes. [Time frame: Preoperative blood draw.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital (PuMCH), Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07029659 · PekingUMCH-OCS