266 Participants Needed

Salpingectomy for Preventing Ovarian Cancer

Recruiting at 9 trial locations
KL
MW
Overseen ByMartin Weiser, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine interest in salpingectomy, a surgery to remove the fallopian tubes, as a potential preventive measure against ovarian cancer after participants watch an informative video. Participants will complete surveys before and after the video to share their thoughts. The trial is open to females or those assigned female at birth, who are over 45, have at least one fallopian tube, and do not plan to have more children. Participants should also be scheduled for non-gynecologic surgery in the abdomen or pelvis. The study involves no treatment changes, focusing solely on gathering opinions about the surgery. As an unphased trial, it offers a unique opportunity to contribute to research that could influence future preventive strategies for ovarian cancer.

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 prior data suggests that salpingectomy is safe for preventing ovarian cancer?

Research has shown that salpingectomy, a surgery to remove the fallopian tubes, is generally safe. Studies have found that this procedure can reduce the risk of ovarian cancer by up to 80%. Importantly, it does not harm the ovaries, allowing them to function normally. Additionally, the surgery adds minimal time to an operation. Overall, salpingectomy is well-tolerated with minimal risk of complications.12345

Why are researchers excited about this trial?

The salpingectomy procedure is unique because it targets the fallopian tubes rather than the ovaries themselves to prevent ovarian cancer. Researchers are excited about this approach because many ovarian cancers are believed to originate in the fallopian tubes, so removing them could significantly reduce cancer risk. Unlike traditional methods like surveillance or prophylactic oophorectomy (removal of the ovaries), a salpingectomy preserves the ovaries, potentially maintaining hormonal balance and reducing long-term health impacts for women.

What evidence suggests that salpingectomy might be an effective preventive treatment for ovarian cancer?

Research has shown that removing the fallopian tubes, a procedure called salpingectomy, can lower the risk of ovarian cancer by about 80%. Studies confirm that this procedure is safe and affordable. This significant risk reduction applies even to women with an average risk of developing ovarian cancer. In this trial, participants scheduled for non-gynecologic abdominopelvic surgery will undergo salpingectomy to evaluate its effectiveness in preventing ovarian cancer. The procedure is increasingly recognized as an effective preventive measure against ovarian cancer.14678

Who Is on the Research Team?

KL

Kara Long Roche, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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
See 7 more

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.
See 9 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants scheduled for non-gynecologic abdominopelvic surgeryExperimental Treatment2 Interventions

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

🇺🇸
Approved in United States as Salpingectomy for:
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Approved in European Union as Salpingectomy for:
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Approved in Canada as Salpingectomy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

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.
Risks and Benefits of Salpingectomy at the Time of Sterilization.Castellano, T., Zerden, M., Marsh, L., 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.
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.
[Prophylactic salpingectomy or salpingo-oophorectomy as an ovarian cancer prevention?].Chene, G., Lamblin, G., Le Bail-Carval, K., et al.[2016]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37672283/
Salpingectomy for the Primary Prevention of Ovarian CancerSalpingectomy has been associated with ovarian cancer risk reduction of approximately 80%. Studies have demonstrated that salpingectomy was safe, cost- ...
Salpingectomy for the Primary Prevention of Ovarian CancerSalpingectomy has been associated with ovarian cancer risk reduction of approximately 80%. Studies have demonstrated that salpingectomy was safe, cost-effective ...
Outcomes From Opportunistic Salpingectomy for Ovarian ...This cohort study examines observed vs expected rates of ovarian cancer among individuals who have undergone opportunistic salpingectomy.
FIGO position statement on opportunistic salpingectomy as an ...Studies show that bilateral salpingectomy (BS) significantly reduces ovarian cancer incidence even in average-risk women. Bilateral ...
Prophylactic salpingectomy as a preventative strategy for ...Bilateral salpingectomy (BS) has been shown to reduce OC risk in cohort studies and systematic reviews [10, 11]. Additionally, Yoon et al. [12] ...
Opportunistic Salpingectomy as a Strategy for Epithelial ...In the Swedish study, women who underwent bilateral salpingectomy had a 65% reduction in the risk of ovarian cancer and women who underwent sterilization had a ...
Salpingectomy for the Primary Prevention of Ovarian CancerSalpingectomy has been associated with ovarian cancer risk reduction of approximately 80%. Studies have demonstrated that salpingectomy was safe ...
To prevent ovarian cancers, fallopian tube removal is on the riseThose who'd had both tubes removed had half the ovarian cancer risk of those who'd had only one tube out, as if the surgery were a preventive ...
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