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Risk-Reducing Surgeries for Hereditary Ovarian Cancer

NCT ID: NCT03294343

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2023-09-01

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HBOCS

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.

Group Type EXPERIMENTAL

salpingo-oophorectomy only by laparoscopy

Intervention Type 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.

Lynch syndromes

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.

Group Type EXPERIMENTAL

salpingo-oophorectomy with hysterectomy by laparoscopy

Intervention Type 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.

Refusal to surgery

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.

Group Type OTHER

Follow-up

Intervention Type 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

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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

Intervention Type OTHER

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.
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, China/Beiing, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, MD

Role: CONTACT

Phone: 13911988831

Email: [email protected]

Facility Contacts

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Lei L Li, MD

Role: primary

Other Identifiers

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SOHHO

Identifier Type: -

Identifier Source: org_study_id