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Validation of potential diagnostic value of OCS score based on exosome diagnostics technology for epithelial ovarian cancer: a prospective, multicenter study

Validation of potential diagnostic value of OCS score based on exosome diagnostics technology for epithelial ovarian cancer: a prospective, multicenter study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099043
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Epithelial varian cancer

Interventions

Gold Standard:Pathological diagnosis

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged >=18 years; 2. Have a suspicious adnexal mass presumed to be of gynaecological orgin; 3. Agree to undergo surgery, and postoperative pathological results are considered available ; 4. Results of pelvic imaging, including ultrasound, MRI,CT or PET/CT, are available ; 5. Able to provide adequate volume of blood samples for serum biomarker tests; 6. Provision of signed and dated informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding; 2. Only have cysts considered physiologic and less than 3 cm in maximum diameter; 3. Have undergone surgery, and pathological results of ovarian tissue have been obtained; 4. Diagnosed as recurrent ovarian cancer; 5. Have received chemotherapy or pelvic radiotherapy within 6 months before sample collection; 6. Have other active primary malignancy; 7. Ineligible for surgery or postoperative pathological results are considered unavailable.

Design outcomes

Primary

MeasureTime frame
Sensitivity of OCS for Diagnosis of Epithelial Ovarian Cancer;Specificity of OCS for Diagnosis of Epithelial Ovarian Cancer;Area under Receiver Operating Characteristic Curve of OCS for Diagnosis of Epithelial Ovarian Cancer;

Secondary

MeasureTime frame
Sensitivity of OCS for Diagnosis of Stage I/II Epithelial Ovarian Cancer;Positive Predictive Value of OCS for Diagnosis of Epithelial Ovarian Cancer;Negative Predictive Value of OCS for Diagnosis of Epithelial Ovarian Cancer;Sensitivity of OCS for Diagnosis of High-grade Serous Ovarian Cancer;

Countries

China

Contacts

Public ContactKun Song

Qilu Hospital of Shandong University

songkun2001226@sdu.edu.cn+86 185 6008 1986

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026