Clinical trial · Observational
Development and Validation of an Ovarian Cancer Risk Prediction Model for Family Members of Ovarian Cancer Probands
Development and Validation of an Ovarian Cancer Risk Prediction Model for Family Members of Ovarian Cancer Probands With BRCA1/2 Germline Mutations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA Mutations | — | UNRESOLVED | — |
| Hereditary Breast and Ovarian Cancer Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| risk-reducing salpingo-oophorectomy (RRSO) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Members of ovarian cancer families carrying BRCA1/2 germline mutations
- description
- Members of ovarian cancer families carrying BRCA1/2 germline mutations，telephone follow-ups will be conducted once a year to longitudinally monitor ovarian cancer incidence and to collect diagnostic evidence.
- interventionNames
- Procedure: risk-reducing salpingo-oophorectomy (RRSO)
Primary outcomes (1)
- measure
- The age at which pathologically diagnosed with ovarian malignant tumors (ICD-10 C56)
- timeFrame
- From enrollment to the end of follow-up at 5 years
- description
- The age at which pathologically diagnosed with ovarian malignant tumors (ICD-10 C56)
Secondary outcomes (1)
- measure
- Acceptance rate of risk-reducing salpingo-oophorectomy (RRSO) among BRCA1/2 mutation carriers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available