Salpingectomy for Preventing Ovarian Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Kara Long Roche, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

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

No Placebo Group

Approved in 3 Jurisdictions

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.

Trial 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 (Procedure)

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 Canada for the following indications:

Approved in Canada as Salpingectomy for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins University (Data Collection Only) Baltimore, MD

Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale, NY

Memorial Sloan Kettering Monmouth (Limited protocol activities) Middletown, NJ

Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison, NY

More Trial Locations

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1998

Patients Recruited

602,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]