Risk-Reducing Surgeries for Hereditary Ovarian Cancer

NCT03294343 | Unknown

• 1 other identifier: SOHHO
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Occult cancer or precancerous lesion in histological specimen

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

  5 years

Secondary Outcomes (3)

• Overall survival

  10 years

• Incidence of primary peritoneal carcinoma

  10 years

• Incidence of primary uterine cancer

  10 years

Study Arms (3)

HBOCS

EXPERIMENTAL

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

Lynch syndromes

EXPERIMENTAL

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

Refusal to surgery

OTHER

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

Interventions

salpingo-oophorectomy only by laparoscopy PROCEDURE

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.

HBOCS

salpingo-oophorectomy with hysterectomy by laparoscopy PROCEDURE

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.

Lynch syndromes

Follow-up OTHER

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

Refusal to surgery

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Without children.
• Not reaching appreciate ages.
• With contraindications of laparoscopy.
• Refusal of risk-reducing surgeries.

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

RECRUITING

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome; Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Salpingo-oophorectomy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ovariectomy; Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures; Salpingectomy

Study Officials

• Lei Li, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, MD

CONTACT

13911988831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

CN (1)