Hysterectomy Clinical Trial
Official title:
Risk-Reducing Surgeries of Salpingo-oophorectomy With/Without Hysterectomy for Carriers With Mutation Genes of Hereditary Ovarian Cancer
Based on studies of "Inherited Susceptible Genes Among Epithelial Ovarian Cancer" (NCT03015376, clinicaltrials.gov) and "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov), we provide risk-reducing surgeries of salpingo-oophorectomy with/without hysterectomy for healthy carriers with mutation genes of hereditary ovarian cancer, which is defined ovarian cancer with relevant pathogenic mutations.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | September 1, 2023 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years and older |
Eligibility |
Inclusion Criteria: - Carriers with known and definite mutation genes of hereditary ovarian cancer. - With children and without further requirement of pregnancy. - No less than 35 years for carriers with mutation gene of BRCA1. - No less than 40 years for carriers with mutation gene of BRCA2. - No less than 45 years for carriers with mutation genes of BRIP1, RAD51C, RAD51D and RAD51. - No less than 50 years for carriers with mutation genes of ATM, MSH2, MLH1, SH6, PMS2, EPCAM and STK11. Exclusion Criteria: - Without children. - Not reaching appreciate ages. - With contraindications of laparoscopy. - Refusal of risk-reducing surgeries. |
Country | Name | City | State |
---|---|---|---|
China | Lei Li | Beijing | China/Beiing |
Lead Sponsor | Collaborator |
---|---|
Lei Li |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occult cancer or precancerous lesion in histological specimen | Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN) | 5 years | |
Secondary | Overall survival | Duration from surgery to death | 10 years | |
Secondary | Incidence of primary peritoneal carcinoma | Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy | 10 years | |
Secondary | Incidence of primary uterine cancer | Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy | 10 years |
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