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Risk-Reducing Surgeries for Hereditary Ovarian Cancer

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
salpingo-oophorectomy only by laparoscopy
salpingo-oophorectomy with hysterectomy by laparoscopy
Follow-up
Sponsored by
Lei Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hereditary Breast and Ovarian Cancer Syndrome

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Lei LiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

HBOCS

Lynch syndromes

Refusal to surgery

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Occult cancer or precancerous lesion in histological specimen
Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)

Secondary Outcome Measures

Overall survival
Duration from surgery to death
Incidence of primary peritoneal carcinoma
Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy
Incidence of primary uterine cancer
Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy

Full Information

First Posted
September 22, 2017
Last Updated
December 22, 2017
Sponsor
Lei Li
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1. Study Identification

Unique Protocol Identification Number
NCT03294343
Brief Title
Risk-Reducing Surgeries for Hereditary Ovarian Cancer
Official Title
Risk-Reducing Surgeries of Salpingo-oophorectomy With/Without Hysterectomy for Carriers With Mutation Genes of Hereditary Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Breast and Ovarian Cancer Syndrome, Colorectal Neoplasms, Hereditary Nonpolyposis, Ovariectomy, Hysterectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HBOCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Lynch syndromes
Arm Type
Experimental
Arm Description
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.
Arm Title
Refusal to surgery
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
salpingo-oophorectomy only by laparoscopy
Intervention Description
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
Intervention Name(s)
salpingo-oophorectomy with hysterectomy by laparoscopy
Intervention Description
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
Other
Intervention Name(s)
Follow-up
Intervention Description
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
Primary Outcome Measure Information:
Title
Occult cancer or precancerous lesion in histological specimen
Description
Precancerous lesions include serous tubal intraepithelial carcinoma (STIC) and endometrial intraepithelial neoplasia (EIN)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Duration from surgery to death
Time Frame
10 years
Title
Incidence of primary peritoneal carcinoma
Description
Incidence of primary peritoneal carcinoma after reception or refusal risk-reducing salpingo-oophorectomy
Time Frame
10 years
Title
Incidence of primary uterine cancer
Description
Incidence of primary uterine cancer after reception or refusal risk-reducing hysterectomy
Time Frame
10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, MD
Phone
13911988831
Ext
+86
Email
lileigh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
China/Beiing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei L Li, MD
Phone
13911988831
Ext
+86
Email
lileigh@163.com
First Name & Middle Initial & Last Name & Degree
Ming Wu, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Risk-Reducing Surgeries for Hereditary Ovarian Cancer

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