adnexal mass
Conditions
Interventions
Gold Standard: pathological diagnosis. If no surgery is performed by the end of the one-year follow-up period, the final diagnosis will be completed via transvaginal ultrasound (TVU) reexamination.
Index test:Ovarian Cancer Score(OCS)
Sponsors
The Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Female aged >= 18 years; 2.Transvaginal ultrasound (TVU) indicates adnexal masses of unknown nature (O-RADS Category 3 + 4), and the masses are presumed to be of gynecological origin; 3.Patients who do not meet the surgical indications agree to receive follow-up observation for one year; 4.Sufficient samples are available for serological marker testing; 5.oluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women; 2.Cysts considered obviously physiological with a maximum diameter of less than 3 cm do not meet the inclusion criteria; 3.Patients diagnosed with ovarian cancer who have undergone surgery and obtained histopathological examination results; 4.Patients with recurrent ovarian cancer as confirmed by researchers, or ovarian cancer patients who have received chemotherapy and/or surgical treatment; 5.Patients who have received chemotherapy or pelvic radiotherapy within 6 months before sample collection; 6.Patients with other primary malignant tumors; 7.Patients with contraindications to surgical evaluation and those for whom ovarian pathology or surgical pathology information cannot be obtained; 8.Samples that do not meet the collection and storage requirements for the reagents used in the evaluation; 9.Contaminated or suspected contaminated samples; 10.Samples with missing, incomplete, or untraceable clinical data of the corresponding patients; 11.Patients with severe systemic diseases; 12.Patients with ovarian endometrioid cysts or inflammatory cysts (e.g., tubo-ovarian abscesses) clearly diagnosed by ultrasound; 13.Patients with pathologically confirmed non-epithelial ovarian malignant tumors (e.g., sarcomas, germ cell tumors) after surgery. Note: If imaging suggests a non-epithelial origin but postoperative pathology confirms epithelial ovarian cancer, the patient will still be included in the analysis; if postoperative pathology confirms a non-epithelial malignant tumor, the patient will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Receiver Operating Characteristic Curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive Predictive Value;Negative Predictive Value; | — |
Countries
China
Contacts
Public ContactMo Chen
The Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed