Surgical Procedures for Reducing Ovarian Cancer Risk (SOROCk Trial)
Recruiting in Palo Alto (17 mi)
+459 other locations
Overseen ByDouglas A Levine
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NRG Oncology
No Placebo Group
Trial Summary
What is the purpose of this trial?This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on cytotoxic chemotherapy, you must not have received it within the past 30 days to be eligible.
What data supports the effectiveness of the treatment Bilateral Salpingectomy and related procedures for reducing ovarian cancer risk?
Risk-reducing bilateral salpingo-oophorectomy (RRSO) has been shown to reduce ovarian cancer deaths in high-risk women, particularly those with BRCA1/2 mutations. However, the effectiveness of bilateral salpingectomy alone in reducing ovarian cancer risk remains unclear, though it is being studied for its safety and acceptability.
12345Is the surgical procedure for reducing ovarian cancer risk safe?
Studies suggest that procedures like bilateral salpingectomy and salpingo-oophorectomy are generally safe, but they can lead to early menopause and hormone deficiency, which have their own risks. Some women may also develop a rare cancer called primary peritoneal carcinomatosis after the surgery.
12367How does the treatment Bilateral Salpingectomy with Oophorectomy differ from other treatments for reducing ovarian cancer risk?
Bilateral Salpingectomy with Oophorectomy is unique because it involves the removal of both fallopian tubes and sometimes the ovaries to reduce ovarian cancer risk, especially in women with genetic predispositions. This approach is different from other treatments as it is often performed opportunistically during other surgeries like hysterectomy or sterilization, and it aims to prevent cancer by removing tissues where cancer often starts.
15689Eligibility Criteria
This trial is for women aged 35-50 with a BRCA1 mutation, who are considering or have deferred risk-reducing surgery of the fallopian tubes and ovaries. They must be medically fit for surgery, not currently have ovarian cancer, and understand they can't naturally conceive post-surgery.Inclusion Criteria
I am between 35 and 50 years old.
I have a confirmed BRCA1 mutation.
I am a woman aged between 35 and 50.
Exclusion Criteria
I am not healthy enough for my planned surgery.
I have had ovarian, peritoneal, or fallopian tube cancer before.
I have had cancer before and received chemotherapy in the last 30 days or radiation to my abdomen or pelvis at any time.
Participant Groups
The study compares two surgeries to lower ovarian cancer risk in women with BRCA1 mutations: removal of both fallopian tubes (bilateral salpingectomy) and removal of both tubes and ovaries (salpingo-oophorectomy). It includes quality-of-life assessments and regular ultrasounds.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (bilateral salpingectomy)Experimental Treatment6 Interventions
Patients undergo bilateral salpingectomy. Patients may then undergo oophorectomy after initial surgery. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.
Group II: Group II (bilateral salpingo-oophorectomy)Active Control6 Interventions
Patients undergo bilateral salpingo-oophorectomy. Patients also undergo a pelvic or transvaginal ultrasound during screening and blood sample collection throughout the trial.
Bilateral Salpingectomy is already approved in Canada, United States, European Union for the following indications:
🇨🇦 Approved in Canada as Opportunistic Salpingectomy for:
- Prevention of ovarian cancer
- Specifically high-grade serous carcinoma (HGSC)
🇺🇸 Approved in United States as Bilateral Salpingectomy for:
- Prevention of ovarian cancer
- Specifically high-grade serous carcinoma (HGSC)
🇪🇺 Approved in European Union as Salpingectomy for:
- Prevention of ovarian cancer
- Specifically high-grade serous carcinoma (HGSC)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
City of Hope SeacliffHuntington Beach, CA
Kaiser Permanente - Panorama CityPanorama City, CA
Huntington Memorial HospitalPasadena, CA
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, FL
More Trial Locations
Loading ...
Who is running the clinical trial?
NRG OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Ovarian cancer incidence and death in average-risk women undergoing bilateral salpingo-oophorectomy at benign hysterectomy. [2022]Opportunistic bilateral salpingo-oophorectomy is often offered to patients undergoing benign hysterectomy to prevent ovarian cancer, but the magnitude of risk reduction obtained with bilateral salpingo-oophorectomy in this population remains unclear and must be weighed against potential risks of ovarian hormone deficiency.
Bilateral salpingectomy with delayed oophorectomy for ovarian cancer risk reduction: A pilot study in women with BRCA1/2 mutations. [2022]Risk-reducing salpingo-oophorectomy (RRSO) reduces ovarian cancer risk in BRCA1/2 mutation carriers, but the adverse effects of the associated early-onset surgical menopause are problematic. Despite suggestive evidence, no data demonstrate whether bilateral salpingectomy alone lowers the risk of developing ovarian cancer in BRCA mutation carriers. We conducted a pilot study of bilateral salpingectomy with delayed oophorectomy (BS/DO) in BRCA mutation carriers to determine the safety and acceptability of the procedure.
Exploring factors that impact uptake of risk-reducing bilateral salpingo-oophorectomy (RRBSO) in high-risk women. [2021]Only risk-reducing bilateral salpingo-oophorectomy (RRBSO) has been shown to reduce ovarian cancer deaths in high-risk women. Uptake of RRBSO is, however, suboptimal and reasons are not well defined. More information is needed about the barriers to RRBSO and patient needs for information and care.
Feasibility and Outcomes of Opportunistic Bilateral Salpingectomy in Patients with Traditional Relative Contraindications to Vaginal Hysterectomy. [2021]To compare the feasibility of opportunistic bilateral salpingectomy (OBS) at the time of vaginal hysterectomy (VH) for benign disease in patients with and without relative contraindications (RCs) to the vaginal approach and to evaluate the factors that contribute to the inability to perform OBS.
Adherence to risk-reducing salpingo-oophorectomy guidelines among gynecologic oncologists compared to general gynecologists. [2023]Risk-reducing bilateral salpingo-oophorectomy reduces mortality from high-grade serous carcinoma in patients with hereditary breast and ovarian cancer associated gene mutations. Ideal surgical management includes 5 steps outlined in 2005 by the Society of Gynecologic Oncology and the American College of Obstetricians and Gynecologists. In addition, it is recommended that pathologic examination include serial sectioning of specimens. In practice, risk-reducing salpingo-oophorectomy is performed by both gynecologic oncologists and general gynecologists. To ensure optimal detection of occult malignancy, standardized adherence to outlined guidelines is necessary.
The effect of prophylactic bilateral salpingectomy on ovarian reserve in patients who underwent laparoscopic hysterectomy. [2023]Bilateral salpingectomy has been proposed to reduce the risk of ovarian cancer, but it is not clear whether the surgery affects ovarian reserve. This study compares the impact of laparoscopic hysterectomy for benign disease with or without prophylactic bilateral salpingectomy on ovarian reserve.
Malignancies following bilateral salpingo-oophorectomy (BSO). [2007]Prophylactic bilateral salpingo-oophorectomy (BSO) is an effective risk reducing measure in ovarian cancer susceptible women. Yet, a small subset of women develop primary peritoneal carcinomatosis (PPC) after BSO. The rates of PPC following non-risk reducing BSO have sparingly been reported.
Risks and Benefits of Salpingectomy at the Time of Sterilization. [2022]Bilateral salpingectomy reduces the risk ovarian cancer. The Society of Gynecologic Oncology has recommended surgeons discuss salpingectomy with patients desiring sterilization.
[Opportunistic Salpingectomy for Permanent Contraception: A Cross Sectional Study in Portugal]. [2021]Opportunistic bilateral salpingectomy has been proposed as an ovarian cancer risk-reducing strategy namely as a means of tubal sterilization. We aimed to assess what were the procedures for interval and peripartum sterilization carried out nationwide, related motivational aspects and influential demographic or professional factors.