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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help doctors tell the difference between endometriosis—a common condition where tissue similar to the lining inside the uterus grows outside it—and a rare type of ovarian cancer that can be linked to endometriosis. The study will test whether a special blood test looking for tiny particles called exosomes can accurately identify whether a patient has just endometriosis or has developed this type of ovarian cancer. The results from this blood test will be compared to the standard diagnosis made after surgery.

Women who are 18 years or older, have been newly diagnosed with either endometriosis or this ovarian cancer based on symptoms and imaging tests like ultrasounds or MRIs, and are scheduled for surgery to treat their condition may be eligible to join. Participants will need to agree to surgery and provide blood samples before their operation. After surgery, doctors will use tissue from the ovaries to confirm the diagnosis and see how well the blood test worked. Women who are pregnant, have had previous ovarian surgery, recent cancer treatments, or other cancers will not be able to join. This study is not yet enrolling patients but aims to improve diagnosis and help guide better treatment decisions in the future.

Gender

FEMALE

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.