Recruiting

Development and Validation of an Ovarian Cancer Risk Prediction Model for Family Members of Ovarian Cancer Probands

ClinicalTrials.gov IDNCT07039552

PhaseNot Applicable

Enrollment10000

SponsorPeking University Third Hospital

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Hereditary Breast and Ovarian Cancer Syndrome, BRCA Mutations

About this study

Ovarian cancer is the gynecological malignancy with the highest fatality rate, seriously threatening the life and health of women. One of the main reasons for its high fatality rate is that approximately 70% of patients are diagnosed at an advanced stage. Fortunately, about 1/5 of ovarian cancers are associated with genetic factors, providing us with an opportunity to screen high-risk populations and thereby prevent and diagnose the disease at an early stage and reduce the disease burden. Currently, research related to hereditary ovarian cancer in China is still very scarce, and clinical practice relies on data from foreign studies. However, hereditary tumors have distinct regional and ethnic characteristics, making it urgent to conduct clinical research based on the Chinese population to guide clinical practice in China. Current research suggests that approximately 50% - 60% of hereditary ovarian cancers are closely related to the BRCA1/2 genes. Therefore, accurately assessing the risk of ovarian cancer in BRCA1/2 germline mutation carriers is of great significance for the prevention and treatment of hereditary ovarian cancer.

Interventions

Procedure: risk-reducing salpingo-oophorectomy (RRSO) — The proportion of BRCA1/2 germline mutation carriers in the high-risk population of ovarian cancer who undergo risk-reducing salpingo-oophorectomy (RRSO). RRSO refers to the preventive surgical removal of both fallopian tubes and ovaries to reduce the risk of ovarian cancer, fallopian tube cancer, and peritoneal cancer.

Primary outcomes

The age at which pathologically diagnosed with ovarian malignant tumors (ICD-10 C56) (From enrollment to the end of follow-up at 5 years)

Eligibility information

Inclusion Criteria: * Pathologically diagnosed with ovarian malignant tumor. * Identified as carriers of BRCA1/2 germline pathogenic or likely pathogenic mutations through genetic testing, in accordance with the "Standards and Guidelines for the Interpretation of Sequence Variants" (2015 Edition) of the American College of Medical Genetics and Genomics (ACMG). * Age of 18 years or older. ④ Voluntary participation in this research and signing of the informed consent form. Exclusion Criteria: * ① Patients who refuse to provide necessary information.

Study locations

Peking University Third Hospital, Beijing, Beijing Municipality 100191 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.