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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, MD | Contact | 13911988831 | +86 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | China/Beiing | 100000 | China |
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| ID | Term |
|---|---|
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
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| ID | Term |
|---|---|
| D000074868 | Salpingo-oophorectomy |
| ID | Term |
|---|---|
| D010052 | Ovariectomy |
| D002369 | Castration |
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 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. |
|
| 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 |
|
| 10 years |
| Incidence of primary uterine cancer | Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy | 10 years |
| D004701 |
| Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013519 |
| Urogenital Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D058994 | Salpingectomy |