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A prospective cohort study on the ability of OCS to distinguish benign and malignant adnexal masses in patients with slightly elevated CA125

A prospective cohort study on the ability of OCS to distinguish benign and malignant adnexal masses in patients with slightly elevated CA125

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111184
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-07-07
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Epithelial ovarian cancer

Interventions

Gold Standard:Pathological diagnosis was adopted as the gold standard in this study
Index test:Detection of human exosomes CA125, HE4 and C5a(OCS)

Sponsors

West China Second University Hospital of Sichuan University (WCSUH- SCU)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Imaging studies (US, CT, MR) suggest space-occupying lesions in the ovaries and fallopian tubes (adnexal area). 2.Serum CA125 ranges from 35 to 200U/ml; 3.Anti-tumor treatment was not carried out before obtaining the OCS blood samples; 4.The research subjects have signed the informed consent and can obtain the complete information and medical records of the patients; 5.Over 18 years old;

Exclusion criteria

Exclusion criteria: 1.There are primary tumors in other organs; 2.Combined with other serious internal medicine diseases: severe abnormalities of heart, liver and kidney functions; Immune or hematological system diseases Severe body Body injury Uncontrolled infectious diseases; 3.Those with poor basic conditions who cannot tolerate surgery (using physical strength scores); 4.Special groups of people who are unable to cooperate with researchers; 5.Previously diagnosed with malignant tumors and received anti-tumor drugs or radiotherapy; 6.There is no pathological diagnosis after the operation or the pathological type cannot be clearly defined; 7.Primary tumors that are not of ovarian or fallopian tube origin are found through imaging or surgery; 8.A history of blood transfusion within three months; 9.After comprehensive assessment by the researcher, it is found that one is not suitable to participate in the research; 10.Has participated in other research projects;

Design outcomes

Primary

MeasureTime frame
Sensitivity ;specificity;

Countries

China

Contacts

Public ContactYuedong He

West China Second University Hospital of Sichuan University (WCSUH- SCU)

He-yd@163.com+86 18180609151

Outcome results

None listed

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