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A prospective observational study evaluating the risk of ovarian cancer in individuals carrying germline mutations in hereditary ovarian cancer-related genes predicted by OCS

A prospective observational study evaluating the risk of ovarian cancer in individuals carrying germline mutations in hereditary ovarian cancer-related genes predicted by OCS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102573
Enrollment
Unknown
Registered
2025-05-16
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-05-19

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:patoegtel dagnesk

Sponsors

The First Medical Center of the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Women aged 35 years or older; 2. Women carrying BRCA1/2 germline mutations or carrying HRR-related mutations (such as germline mutations of RAD51C, RAD51D, BRIP1, PALB2, ATM, etc., and mutations of BARD1, BRIP1, CHEK2, MRE11A, MSH6, NBN, PALB2, RAD50, RAD51C, or TP53, etc.), or patients with Lynch syndrome; 3. Having pelvic imaging evaluation results, including ultrasound, MRI, CT or PET/CT; 4. Having sufficient samples for serological marker examination; 5. Volunteering to participate in this study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Women who have regular follow-up examinations after ovarian cancer surgery; 3. Patients with recurrent ovarian cancer diagnosed by the researchers; 4. Patients who are undergoing chemotherapy or pelvic radiotherapy treatment courses; 5. Patients with other diagnosed primary malignant tumors; 6. Contraindications for surgical evaluation and inability to obtain ovarian pathological or surgical pathological information; 7. Samples that do not meet the requirements for collection and storage of the evaluation reagent samples; 8. Contaminated or suspected to be contaminated samples; 9. Samples with missing, incomplete or untraceable corresponding patient clinical data.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;

Secondary

MeasureTime frame
Positive predictive value;Negative predictive value;Area under ROC curve;

Countries

China

Contacts

Public ContactYe Mingxia

The First Medical Center of the PLA General Hospital

ymx298013@126.com+86 159 0122 9215

Outcome results

None listed

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