Salpingectomy for Preventing Ovarian Cancer

Recruiting at 9 trial locations

Overseen By Martin Weiser, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Gynecologic malignancy, BRCA1/2, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Salpingectomy for preventing ovarian cancer?

Research shows that removing the fallopian tubes (salpingectomy) can significantly lower the risk of ovarian cancer. Studies have found that this procedure, especially when both tubes are removed (bilateral salpingectomy), is effective in reducing the chances of developing ovarian cancer. ^{1 2 3 4 5}

Is salpingectomy generally safe for humans?

Salpingectomy, which involves removing the fallopian tubes, is generally considered safe, with studies focusing on its use to prevent ovarian cancer. It is important to monitor for surgical complications and changes in hormonal status, but it avoids the early menopause associated with removing the ovaries. ^{3 6 7 8 9}

How does salpingectomy differ from other treatments for preventing ovarian cancer?

Salpingectomy, which involves removing the fallopian tubes, is unique because it targets the origin of many ovarian cancers, potentially reducing cancer risk without removing the ovaries, unlike salpingo-oophorectomy, which also removes the ovaries and can lead to early menopause and other health issues. ^{3 4 8 10 11}

Research Team

Kara Long Roche, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for women or individuals assigned female at birth, aged 45 or older, who have at least one fallopian tube and no plans for future children. They should be at average risk for ovarian cancer and scheduled for non-gynecologic abdominal/pelvic surgery. Candidates must understand English, not carry genes linked to ovarian cancer, nor have a history of gynecologic malignancies.

Inclusion Criteria

I have at least one fallopian tube that has not been removed.

I am 45 years old or older.

Part II: Approved and signed informed consent

Exclusion Criteria

I have had cancer in my reproductive organs before.

Part I: Not fluent in English

I carry a gene variant linked to breast or ovarian cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Module

Participants watch an educational video and complete questionnaires before and after viewing

1 day

1 visit (in-person)

Surgical Procedure

Participants undergo non-gynecologic abdominopelvic surgery with the option for Opportunistic Salpingectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for acceptance and outcomes of the surgical procedure

up to 2 years

Treatment Details

Interventions

• Salpingectomy

Trial Overview The study tests if participants are interested in an optional surgical procedure (salpingectomy) to prevent ovarian cancer after watching an educational video. It involves completing questionnaires before and after the video during a clinic visit.

Participant Groups

Group I: Participants scheduled for non-gynecologic abdominopelvic surgery Experimental Treatment 2 Interventions

Participants will be aged ≥45 years, have at least 1 fallopian tube, will not desire or plan to have children in the future, and will be scheduled to undergo non-gynecologic abdominopelvic surgery.

Salpingectomy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Salpingectomy for:

• Ectopic Pregnancy
• Ovarian Cancer Prevention
• Fallopian Tube Cancer
• Peritoneal Cancer

Approved in European Union as Salpingectomy for:

• Ectopic Pregnancy
• Ovarian Cancer Prevention
• Fallopian Tube Cancer
• Peritoneal Cancer

Approved in Canada as Salpingectomy for:

• Ectopic Pregnancy
• Ovarian Cancer Prevention
• Fallopian Tube Cancer
• Peritoneal Cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

A meta-analysis of three studies involving 3509 women who underwent bilateral salpingectomy (BS) found that this procedure significantly reduces the risk of ovarian cancer (OC), with an odds ratio of 0.51 compared to controls.

The findings suggest that prophylactic BS should be considered for women undergoing hysterectomy for benign reasons or sterilization, as it effectively lowers OC risk in the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: A meta-analysis. Yoon, SH., Kim, SN., Shim, SH., et al.[2022]

Bilateral prophylactic salpingo-oophorectomy significantly reduces the risk of breast cancer by about 50% and ovarian cancer by 80-95% in women with BRCA1/2 mutations, but it can lead to menopausal symptoms and decreased quality of life.

Recent studies indicate that hormone replacement therapy after the procedure does not diminish the breast cancer risk reduction benefits, and there may be a short-term mortality benefit for BRCA1/2 mutation carriers following the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic oophorectomy in women at increased cancer risk. Domchek, SM., Rebbeck, TR.[2007]

Bilateral salpingectomy significantly reduces the risk of ovarian cancer while preserving ovarian function, making it a safer alternative to the traditional bilateral salpingo-oophorectomy, which can lead to surgical menopause and increased mortality in younger women.

Recent studies indicate that prophylactic salpingectomy not only helps prevent high-grade serous ovarian cancer but also reduces the occurrence of adnexal pathologies, highlighting its dual benefits in women's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Updates on Salpingectomy for the Prevention of Ovarian Cancer and Its Practice Patterns Worldwide. Dhakal, S., Zheng, YX., Yi, XF.[2022]

Bilateral salpingectomy significantly reduces the risk of ovarian cancer compared to traditional sterilization methods, based on a review of 4 high-quality studies.

The procedure does not appear to have a significant long-term impact on ovarian reserve and offers additional benefits like improved contraceptive efficacy, but it also carries risks such as increased surgical time and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Benefits of Salpingectomy at the Time of Sterilization. Castellano, T., Zerden, M., Marsh, L., et al.[2022]

Bilateral salpingo-oophorectomy significantly reduces the incidence of ovarian cancer by 0.38% over 20 years in women undergoing benign hysterectomy, with a hazard ratio of 0.23, indicating a strong protective effect against developing the disease.

In postmenopausal women (≥50 years), the absolute risk reduction increases to 0.62%, suggesting that this procedure may be particularly beneficial for older women at the time of hysterectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian cancer incidence and death in average-risk women undergoing bilateral salpingo-oophorectomy at benign hysterectomy. Cusimano, MC., Ferguson, SE., Moineddin, R., et al.[2022]

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]

In a pilot study involving 43 pre-menopausal BRCA1/2 mutation carriers, those who underwent bilateral salpingectomy with delayed oophorectomy (BS/DO) experienced no surgical complications and reported high satisfaction with their choice of procedure.

Patients who chose BS/DO showed significant reductions in cancer worry and anxiety levels 12 months post-surgery, indicating that this approach may be a psychologically beneficial alternative to immediate risk-reducing salpingo-oophorectomy (RRSO).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral salpingectomy with delayed oophorectomy for ovarian cancer risk reduction: A pilot study in women with BRCA1/2 mutations. Nebgen, DR., Hurteau, J., Holman, LL., et al.[2022]

Prophylactic bilateral salpingectomy during laparoscopic hysterectomy does not negatively impact ovarian reserve in premenopausal women, as measured by hormone levels and follicle counts before and after surgery.

This surgical approach may help reduce the risk of ovarian cancer without compromising ovarian function, as no significant differences were found in ovarian reserve markers between women who had the salpingectomy and those who did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of prophylactic bilateral salpingectomy on ovarian reserve in patients who underwent laparoscopic hysterectomy. Wang, S., Gu, J.[2023]

Research suggests that most high-grade ovarian and peritoneal serous carcinomas may originate in the fallopian tubes, highlighting the importance of understanding this new tubal carcinogenic sequence.

Adopting prophylactic bilateral salpingectomy instead of traditional salpingo-oophorectomy could reduce ovarian cancer mortality while minimizing the negative effects of surgical menopause, especially for individuals with hereditary risks like BRCA mutation carriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical implications of the potential new tubal pathway for ovarian carcinogenesis. Chene, G., Rahimi, K., Mes-Masson, AM., et al.[2022]

Recent studies suggest that the distal fimbriae end of the fallopian tubes is a primary precursor to high-grade serous carcinoma, which is a common type of ovarian cancer.

Removing the fallopian tubes while preserving the ovaries (bilateral salpingectomy) may significantly reduce the risk of developing ovarian cancer in both high-risk and low-risk women, making it a promising primary prevention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic salpingectomy and prophylactic salpingoophorectomy for adnexal high-grade serous epithelial carcinoma: A reappraisal. Oliver Perez, MR., Magriñá, J., García, AT., et al.[2022]

Recent research suggests that many ovarian cancers, particularly high-grade serous types, may originate from the fallopian tubes, indicating a potential new target for prevention strategies.

Bilateral salpingectomy (removal of the fallopian tubes) could be a safer alternative to oophorectomy (removal of ovaries) for BRCA mutation carriers and the general population, as it may reduce the risk of ovarian cancer while minimizing negative effects on cardiovascular health and other functions in premenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prophylactic salpingectomy or salpingo-oophorectomy as an ovarian cancer prevention?]. Chene, G., Lamblin, G., Le Bail-Carval, K., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Bilateral salpingectomy can reduce the risk of ovarian cancer in the general population: A meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Prophylactic oophorectomy in women at increased cancer risk. [2007]

3. China pubmed.ncbi.nlm.nih.gov

Current Updates on Salpingectomy for the Prevention of Ovarian Cancer and Its Practice Patterns Worldwide. [2022]

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

Risks and Benefits of Salpingectomy at the Time of Sterilization. [2022]

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

Ovarian cancer incidence and death in average-risk women undergoing bilateral salpingo-oophorectomy at benign hysterectomy. [2022]

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

Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. [2022]

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

Bilateral salpingectomy with delayed oophorectomy for ovarian cancer risk reduction: A pilot study in women with BRCA1/2 mutations. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The effect of prophylactic bilateral salpingectomy on ovarian reserve in patients who underwent laparoscopic hysterectomy. [2023]

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

Surgical implications of the potential new tubal pathway for ovarian carcinogenesis. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Prophylactic salpingectomy and prophylactic salpingoophorectomy for adnexal high-grade serous epithelial carcinoma: A reappraisal. [2022]

11. France pubmed.ncbi.nlm.nih.gov

[Prophylactic salpingectomy or salpingo-oophorectomy as an ovarian cancer prevention?]. [2016]