Risk-Reducing Surgeries for Hereditary Ovarian Cancer

Lei Li

Status: Unknown

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

Treatments: Procedure: salpingo-oophorectomy only by laparoscopy; Other: Follow-up; Procedure: salpingo-oophorectomy with hysterectomy by laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03294343

SOHHO

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

HBOCS

Experimental group

Description:

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.

Treatment:

Procedure: salpingo-oophorectomy only by laparoscopy

Lynch syndromes

Experimental group

Description:

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.

Treatment:

Procedure: salpingo-oophorectomy with hysterectomy by laparoscopy

Refusal to surgery

Other group

Description:

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.

Treatment:

Other: Follow-up