Risk-Reducing Surgeries for Hereditary Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Risk-Reducing Surgeries of Salpingo-oophorectomy With/Without Hysterectomy for Carriers With Mutation Genes of Hereditary Ovarian Cancer

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

Intervention / Treatment
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* Procedure: salpingo-oophorectomy only by laparoscopy
* Procedure: salpingo-oophorectomy with hysterectomy by laparoscopy
* Other: Follow-up


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBOCS<br>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. | Procedure: salpingo-oophorectomy only by laparoscopy<br>* 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.<br>|
| Experimental: Lynch syndromes<br>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. | Procedure: salpingo-oophorectomy with hysterectomy by laparoscopy<br>* 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.<br>|
| Other: Refusal to surgery<br>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. | Other: Follow-up<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occult cancer or precancerous lesion in histological specimen | Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Duration from surgery to death | 10 years | 
| Incidence of primary peritoneal carcinoma | Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy | 10 years | 
| Incidence of primary uterine cancer | Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy | 10 years |