Risk-Reducing Surgeries for Hereditary Ovarian Cancer

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03294343
• Other study ID #: SOHHO
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2017
• Last updated: December 22, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2017
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, MD
• Phone: 13911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• salpingo-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.
• salpingo-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.

Other:
• Follow-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

Locations

Country	Name	City	State
China	Lei Li	Beijing	China/Beiing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occult cancer or precancerous lesion in histological specimen	Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)	5 years
Secondary	Overall survival	Duration from surgery to death	10 years
Secondary	Incidence of primary peritoneal carcinoma	Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy	10 years
Secondary	Incidence of primary uterine cancer	Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy	10 years