Salpingectomy with Delayed Oophorectomy for Ovarian Cancer

Recruiting at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Postmenopausal, No BRCA mutation, Ovarian cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

80 Participants Needed

Trial Summary

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, it allows for the use of SERMs (selective estrogen receptor modulators) or aromatase inhibitors, so you may be able to continue these if applicable.

What data supports the effectiveness of the treatment Prophylactic Salpingectomy with Delayed Oophorectomy for preventing ovarian cancer?

Research suggests that removing the fallopian tubes first and delaying the removal of the ovaries can be a safe and effective way to reduce the risk of ovarian cancer in high-risk women, while also avoiding early menopause. This approach is based on the understanding that the fallopian tubes play a key role in the development of ovarian cancer. ^{1 2 3 4 5}

Is salpingectomy with delayed oophorectomy safe for humans?

Research shows that salpingectomy with delayed oophorectomy is generally safe and well-tolerated, with few complications reported. In a study, only minor surgical complications occurred, and no severe post-operative issues were noted, making it a promising option for those at high risk of ovarian cancer. ^{1 2 5 6 7}

How does the treatment 'Prophylactic Salpingectomy with Delayed Oophorectomy' differ from other treatments for ovarian cancer?

This treatment involves removing the fallopian tubes first and delaying the removal of the ovaries, which can help prevent early menopause and its associated health issues, unlike the standard approach of removing both at once. ^{1 2 3 8 9}

What is the purpose of this trial?

The goal of this clinical research study is to compare ovarian cancer screening, risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed oophorectomy (PSDO). The safety of RRSO and PSDO will also be studied. Ovarian cancer screening does not involve a surgical procedure. Instead, physical exams, blood tests, and ultrasound are used to check for ovarian, fallopian tube, and peritoneal cancer. The surgical procedures, RRSO and PSDO, are designed to lower your risk of ovarian cancer. In RRSO, the fallopian tubes and ovaries are removed at the same time. In PSDO, the fallopian tubes are removed and the ovaries remain in place so that the patient does not go through menopause. The ovaries are removed at a later date. The main goal of this study is to learn how many patients actually have their ovaries removed at a later date. Researchers also want to learn whether the removal of fallopian tubes will decrease the risk of ovarian cancer.

Research Team

Denise Nebgen, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for premenopausal women aged 30-47 with a BRCA1 or BRCA2 mutation, who are candidates for surgery and desire permanent sterilization. They must be willing to undergo two surgeries if choosing the PSDO arm and have completed any cancer treatments at least 3 months prior.

Inclusion Criteria

Willingness to return to the enrolling site for ovarian cancer screening during the study period.

I am a woman between 30 and 48 years old.

I had cancer other than ovarian, am now cancer-free, and finished treatment over 3 months ago.

Exclusion Criteria

Women who are pregnant. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgement of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.

Inability to provide informed consent.

Women whose most recent CA125 blood test or transvaginal ultrasound is not normal. If your most recent test is normal, then you can still participate even if you had abnormal tests in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Cancer Screening

Participants undergo physical exams, blood tests, and ultrasounds every 6 months for up to 3 years to screen for ovarian cancer.

3 years

Every 6 months

Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO)

Participants undergo salpingectomy as an outpatient procedure, followed by regular ovarian cancer screening until delayed oophorectomy.

3 years

Regular follow-ups every 6 months

Risk-Reducing Salpingo-Oophorectomy (RRSO)

Participants undergo RRSO as an outpatient procedure, with follow-up visits to monitor recovery and discuss pathology results.

1 year

1 day, 1 week, 1 month, 6 months, and 1 year post-surgery

Follow-up

Participants are monitored annually for changes in medical history after the last study visit.

Long-term

Treatment Details

Interventions

• Prophylactic Salpingectomy with Delayed Oophorectomy

Trial Overview The study compares ovarian cancer screening methods with two surgical procedures: risk-reducing salpingo-oophorectomy (RRSO) where both fallopian tubes and ovaries are removed, and prophylactic salpingectomy with delayed oophorectomy (PSDO), which removes fallopian tubes first, delaying ovary removal.

Participant Groups

Group I: Risk-Reducing Salpingo-Oophorectomy (RRSO) Experimental Treatment 4 Interventions

Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.

Group II: Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) Experimental Treatment 4 Interventions

Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.

Group III: Ovarian Cancer Screening Experimental Treatment 4 Interventions

Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Radical fimbriectomy followed by delayed oophorectomy is a safe and well-tolerated alternative for high-risk women who refuse the standard risk-reducing salpingo-oophorectomy, with no cases of pelvic invasive cancer reported after a median follow-up of 7.3 years.

The study found that while two cases of occult neoplasia were identified, the overall safety profile was strong, with only minor intraoperative complications and no significant postoperative issues, making this approach a viable option to avoid early menopause.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic Radical Fimbriectomy with Delayed Oophorectomy in Women with a High Risk of Developing an Ovarian Carcinoma: Results of a Prospective National Pilot Study. Leblanc, E., Narducci, F., Ferron, G., et al.[2023]

Risk-reducing salpingo-oophorectomy is the only proven intervention that significantly decreases mortality from ovarian cancer in women at increased risk, making it the standard care for risk reduction.

For high-risk premenopausal women, prophylactic salpingectomy followed by delayed oophorectomy is recommended for consideration in clinical trials, suggesting a potential alternative approach to managing ovarian cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options in Prophylactic Surgery to Prevent Ovarian Cancer in High-Risk Women: How New Hypotheses of Fallopian Tube Origin Influence Recommendations. Swanson, CL., Bakkum-Gamez, JN.[2018]

Women with BRCA1/2 pathogenic variants experience better menopause-related quality of life after risk-reducing salpingectomy (RRS) compared to risk-reducing salpingo-oophorectomy (RRSO), with a significant difference in climacteric symptoms observed in a study of 577 women.

The study found that even with hormone replacement therapy, RRS resulted in fewer menopause-related symptoms than RRSO, suggesting that RRS may be a preferable option for women seeking to delay menopause while managing cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Salpingectomy With Delayed Oophorectomy Versus Salpingo-oophorectomy With Quality of Life in BRCA1/2 Pathogenic Variant Carriers: A Nonrandomized Controlled Trial. Steenbeek, MP., Harmsen, MG., Hoogerbrugge, N., et al.[2022]

The study aims to evaluate the impact of risk-reducing early salpingectomy with delayed oophorectomy on sexual function in pre-menopausal women at increased risk of tubo-ovarian cancer, involving 1000 participants across three groups: early salpingectomy, standard salpingo-oophorectomy, and controls.

The hypothesis suggests that early salpingectomy will be non-inferior or superior in terms of sexual and endocrine function compared to standard surgery, potentially offering a safer alternative that avoids premature menopause and its associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Ovarian Cancer through early Excision of Tubes and late Ovarian Removal (PROTECTOR): protocol for a prospective non-randomised multi-center trial. Gaba, F., Robbani, S., Singh, N., et al.[2023]

The review included seven randomized controlled trials with 350 women, but found no studies reporting on the incidence of ovarian cancer after hysterectomy with opportunistic salpingectomy compared to without, indicating a gap in research on this preventive measure.

There was insufficient data to determine differences in surgical adverse events or postoperative hormonal status between the two groups, suggesting that while opportunistic salpingectomy may be safe, its long-term effects, especially on ovarian reserve, need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. van Lieshout, LAM., Steenbeek, MP., De Hullu, JA., et al.[2022]

The study aims to determine if salpingectomy with delayed oophorectomy is as effective as the standard salpingo-oophorectomy in preventing tubo-ovarian cancer in individuals with high inherited risk, specifically BRCA1 and BRCA2 mutation carriers.

This international trial will involve 3000 participants and is designed to assess cancer incidence by comparing outcomes over a follow-up period of at least 10 years, with results expected by 2036.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. Steenbeek, MP., van Bommel, MHD., intHout, J., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Prophylactic Radical Fimbriectomy with Delayed Oophorectomy in Women with a High Risk of Developing an Ovarian Carcinoma: Results of a Prospective National Pilot Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Options in Prophylactic Surgery to Prevent Ovarian Cancer in High-Risk Women: How New Hypotheses of Fallopian Tube Origin Influence Recommendations. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Association of Salpingectomy With Delayed Oophorectomy Versus Salpingo-oophorectomy With Quality of Life in BRCA1/2 Pathogenic Variant Carriers: A Nonrandomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Preventing Ovarian Cancer through early Excision of Tubes and late Ovarian Removal (PROTECTOR): protocol for a prospective non-randomised multi-center trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of prophylactic salpingo-oophorectomy on menopausal symptoms and sexual function in women who carry a BRCA mutation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. [2022]

7. England pubmed.ncbi.nlm.nih.gov

TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Analysis of Prophylactic Salpingo-oophorectomy at the Time of Hysterectomy for Benign Lesions. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 774 Summary: Opportunistic Salpingectomy as a Strategy for Epithelial Ovarian Cancer Prevention. [2020]