Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer

What is the Purpose of this Study?

This study aims to determine whether 2 surgical procedures are no different for ovarian cancer risk reduction in individuals with BRCA1 mutations who have completed childbearing. Researchers will compare the removal of fallopian tubes to the removal of fallopian tubes and ovaries. The study will also examine the factors that go into deciding which surgery to have, as well as evaluate the symptoms after surgery (symptoms caused by lack of estrogen due to ovary removal). The usual treatment approach is surgery to remove the fallopian tubes and ovaries at the same time. Participants will decide whether to undergo surgical removal of fallopian tubes (bilateral salpingectomy) or removal of fallopian tubes and ovaries (bilateral salpingo-oophorectomy).


Eligibility

  • Individuals 35-50 years of age, inclusive
  • Patients who are undergoing risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
  • At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and fallopian tube (with fimbria not removed) are present
  • Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
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Where can I participate?

Cedars-Sinai Cancer at SOCC : Garrett Crook

More about this Clinical Trial

What is the full name of this clinical trial?

A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferirority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]

Study Details
Disease Type/Condition

Ovary

Principal Investigator

Rimel, Bobbie Jo

Co-Investigators

Andrew Li, Kenneth Kim, Kristin Taylor, Margaret Liang

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002931

ClinicalTrials.gov ID

NCT04251052

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Garrett Crook

Email
Garrett.Crook@cshs.org
Study Detail
Disease Type/Condition

Ovary

Principal Investigator

Rimel, Bobbie Jo

Age Group

Adult

Phase

N/A

IRB Number

NRG-CC008

ClinicalTrials.gov ID

NCT04251052

Key Eligibility
ClinicalTrials.gov

Contact
Name

Garrett Crook

Email
Garrett.Crook@cshs.org