Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary Breast and Ovarian Cancer Syndrome, Hysterectomy, Ovariectomy
Conditions
Brief summary
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.
Interventions
PROCEDUREsalpingo-oophorectomy only by laparoscopy
Salpingo-oophorectomy are provided for carriers with mutation genes of BRCA1, BRCA2 (both belonging to mutation genes of hereditary breast and ovarian cancer syndrome, HBOCS) and ATM, BRIP1, RAD51, RAD51C, and RAD51D (all belonging to mutation genes of other hereditary ovarian cancer syndrome). Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.
PROCEDUREsalpingo-oophorectomy with hysterectomy by laparoscopy
Salpingo-oophorectomy with hysterectomy are provided for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11. Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.
OTHERFollow-up
Detailed multi-disciplinary counseling, decision-making analysis and long-term follow-up are provided for carriers with any mutation genes but refusal to any risk-reducing gynecologic surgeries
Sponsors
Lei Li
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occult cancer or precancerous lesion in histological specimen | 5 years | Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 10 years | Duration from surgery to death |
| Incidence of primary peritoneal carcinoma | 10 years | Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy |
| Incidence of primary uterine cancer | 10 years | Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy |
Countries
China
Contacts
Primary ContactLei Li, MD
Outcome results
None listed