Risk-Reducing Surgeries for Hereditary Ovarian Cancer

Not Applicable

• Conditions: Ovariectomy; Hereditary Breast and Ovarian Cancer Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis; Hysterectomy
• Interventions: Procedure: salpingo-oophorectomy with hysterectomy by laparoscopy; Other: Follow-up; Procedure: salpingo-oophorectomy only by laparoscopy

• Registration Number: NCT03294343
• Lead Sponsor: Lei Li

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-26
• Primary Completion: 2022-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lynch syndromes	salpingo-oophorectomy with hysterectomy by laparoscopy	for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11, , if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy with hysterectomy by laparoscopy and long-term follow-up are provided.
Refusal to surgery	Follow-up	For carriers with any mutation genes (BRCA1, BRCA2, ATM, BRIP1, RAD51, RAD51C, RAD51D, STK11, MLH1, MSH2, MSH6, PMS2 and EPCAM) but refusal to any risk-reducing surgeries, counseling, decision-making analysis, and then long-term follow-up are provided.
HBOCS	salpingo-oophorectomy only by laparoscopy	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), if they demand for risk-reducing surgeries, counseling, decision-making analysis, then salpingo-oophorectomy only by laparoscopy and long-term follow-up are provided.

Primary Outcome Measures

Name	Time	Method
Occult cancer or precancerous lesion in histological specimen	5 years	Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)

Secondary Outcome Measures

Name	Time	Method
Overall survival	10 years	Duration from surgery to death
Incidence of primary uterine cancer	10 years	Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy
Incidence of primary peritoneal carcinoma	10 years	Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, China/Beiing, China