Clinical trial · Observational
A Cohort Study of Hereditary Ovarian Cancer Risk Prediction Models and Pathogenesis Exploration
NCT06564428CI-TRIAL-00091154recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this project is to establish a bidirectional multicenter cohort of hereditary ovarian cancer and to describe the clinicopathologic features of hereditary ovarian cancer patients in our country. The risk prediction model of ovarian cancer for Chinese was established by following-up analysis of clinical and pathological information, genetic test results and detailed family history, to predict the risk of cancer in first-degree relatives of carriers of pathogenic/suspected pathogenic mutations, and to guide the intervention management of high-risk population of cancer. The study will identify novel tumor-causing mutations/predisposing genes by gene sequencing in a special family with hereditary tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Suspective gene mutations and family history | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Mutation carriers
- description
- Patients presented to our hospital with a definite pathological diagnosis of epithelial ovarian cancer, who carry suspective gene mutations or have family history of cancer.
- interventionNames
- Genetic: Suspective gene mutations and family history
- label
- Control group
- description
- Patients presented to our hospital with a definite pathological diagnosis of epithelial ovarian cancer, who don't carry any suspective gene mutations and have no family history of any type of cancer.
Primary outcomes (1)
- measure
- The clinicopathological features and gene mutation characteristics of hereditary ovarian cancer
- timeFrame
- 2024-2026
- description
- * personal history (age, BMI, oral contraceptive use, hormone replacement therapy use, tubal ligation) * menstrual marriage and childbearing history (whether or not menopause, menopausal age, menarche age, the number of births) * personal history of tumor (history of malignant tumor, tumor type, pathological type, tumor stage, age of onset) ④family history of cancer (family history of cancer or not, number/person of cancer in first/second/third degree relatives, relationship with patients, tumor type, pathological type, tumor stage, age of onset, gene detection) ⑤results of gene detection (detection items, specimen type, mutation, mutated gene, cDNA change, amino acid change, mutation type, mutation significance)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Epithelial ovarian cancer * ≥18 years * The pathological diagnosis was clear * The genetic test showed germ line pathogenic/suspected pathogenic mutations (for mutation interpretation, refer to the American ACMG Classification Standards and Guidelines for Genetic Variation) Exclusion Criteria: * Non-epithelial ovarian cancer was confirmed by pathology * No genetic test has been performed
References
Publications (19)
- BACKGROUNDLheureux S, Gourley C, Vergote I, Oza AM. Epithelial ovarian cancer. Lancet. 2019 Mar 23;393(10177):1240-1253. doi: 10.1016/S0140-6736(18)32552-2. PMID 30910306
- BACKGROUNDNielsen FC, van Overeem Hansen T, Sorensen CS. Hereditary breast and ovarian cancer: new genes in confined pathways. Nat Rev Cancer. 2016 Sep;16(9):599-612. doi: 10.1038/nrc.2016.72. Epub 2016 Aug 12. PMID 27515922
- BACKGROUNDYoshida R. Hereditary breast and ovarian cancer (HBOC): review of its molecular characteristics, screening, treatment, and prognosis. Breast Cancer. 2021 Nov;28(6):1167-1180. doi: 10.1007/s12282-020-01148-2. Epub 2020 Aug 29. PMID 32862296
- BACKGROUNDLynch HT, Snyder CL, Shaw TG, Heinen CD, Hitchins MP. Milestones of Lynch syndrome: 1895-2015. Nat Rev Cancer. 2015 Mar;15(3):181-94. doi: 10.1038/nrc3878. Epub 2015 Feb 12. PMID 25673086
- BACKGROUNDUS Preventive Services Task Force; Owens DK, Davidson KW, Krist AH, Barry MJ, Cabana M, Caughey AB, Doubeni CA, Epling JW Jr, Kubik M, Landefeld CS, Mangione CM, Pbert L, Silverstein M, Simon MA, Tseng CW, Wong JB. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2019 Aug 20;322(7):652-665. doi: 10.1001/jama.2019.10987. PMID 31429903
- BACKGROUNDGilpin CA, Carson N, Hunter AG. A preliminary validation of a family history assessment form to select women at risk for breast or ovarian cancer for referral to a genetics center. Clin Genet. 2000 Oct;58(4):299-308. doi: 10.1034/j.1399-0004.2000.580408.x. PMID 11076055
- BACKGROUNDEvans DG, Eccles DM, Rahman N, Young K, Bulman M, Amir E, Shenton A, Howell A, Lalloo F. A new scoring system for the chances of identifying a BRCA1/2 mutation outperforms existing models including BRCAPRO. J Med Genet. 2004 Jun;41(6):474-80. doi: 10.1136/jmg.2003.017996.