Risk-Reducing Surgeries for Hereditary Ovarian Cancer

Lei Li600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

Hereditary Breast and Ovarian Cancer Syndrome Colorectal Neoplasms, Hereditary Nonpolyposis Ovariectomy Hysterectomy

Interventions

salpingo-oophorectomy only by laparoscopyPROCEDURE

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.

salpingo-oophorectomy with hysterectomy by laparoscopyPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Lei Li

Beijing, China/Beiing, China

RECRUITING

Outcomes

Primary Outcomes

Occult cancer or precancerous lesion in histological specimen

Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)

Time frame: 5 years

Secondary Outcomes

Overall survival

Duration from surgery to death

Time frame: 10 years

Incidence of primary peritoneal carcinoma

Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy

Time frame: 10 years

Incidence of primary uterine cancer

Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy

Time frame: 10 years

Central Contacts

Lei Li, MD

CONTACT

13911988831 lileigh@163.com

Data from ClinicalTrials.gov

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