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NCT Number: NCT06312124

A Study of Opportunistic Salpingectomy to Prevent Ovarian Cancer

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.

Recruiting

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Key information

Conditions

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University (Data Collection Only), Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Part I

  • Age ≥45 years
  • Scheduled visit with a nongynecologic surgeon
  • Female or assigned female at birth

Part II

  • Age ≥45 years
  • At least one in situ fallopian tube
  • No desire or plan to have children in the future
  • Average risk of developing ovarian cancer

° Note: Average risk patients are defined as patients with no known genetic risk factor for developing ovarian cancer. Patients who, after obtaining family history, are suspected to have a hereditary ovarian cancer syndrome but have not yet been tested, will be referred for genetic evaluation.

  • Planned nongynecologic, intraabdominal, or pelvic surgery
  • Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologic surgeon (for example, on the basis of surgical history and current malignancy status)
  • Approved and signed informed consent

Exclusion criteria

Part I

  • Not fluent in English or Spanish

° If there is a non-english or non-spanish speaking participant who is a strong candidate and meets all other criteria for Part 2, they are able to go directly onto Part 2 without completing Part 1. (Please see additional details in section 4.1 and 7.0.)

  • Known inherited ovarian cancer susceptibility

Part II

  • Personal history of a gynecologic malignancy
  • Carrier of a hereditary breast or ovarian cancer variant (e.g., BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2)
  • Suspicious ovarian, fallopian tube, or uterine lesion on preoperative imaging
  • Previous bilateral salpingectomy or bilateral salpingo-oophorectomy
  • Presence of ESSURE, or other tubal-implanted birth control at the time of surgery
  • Current pregnancy
  • Emergent procedure or emergency procedure that has to be completed within 24 hours where clinical consent occurs in the inpatient setting or where the patient's immediate well-being is in danger or condition may be life threatening
  • Primary surgeon anticipates that OS will add significant time (>30-40min) to the planned procedure.
  • Inability to access the pelvis (ex., patient prone/lateral position) during the planned procedure.
  • Known history of pelvic fibrosis or significant adhesions.
  • Procedures with palliative intent only

Treatment and study plan

Educational module

Behavioral

Part 1 consists of an education module with premodule and postmodule assessment questionnaires.

Salpingectomy

Procedure

Part 2 consists of incorporating opportunistic salpingectomy /OS into non-gynecologic surgery

Primary outcomes

  1. Rate of Opportunistic Salpingectomy/OS after completion of educational module

    Time frame: up to 2 years

    Evaluate the acceptance of Opportunistic Salpingectomy/OS among nongynecologic surgical patients after completion of an educational module

Study contacts

Contact information is provided by the study sponsor or research team.

Kara Long Roche, MD

CONTACT

[email protected]

212-639-7043

Martin Weiser, MD

CONTACT

[email protected]

212-639-6698

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 15, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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