Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05287451
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RIsk-Reducing Salpingectomy (RRS) — OTHER
    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
  • Risk-Reducing Oophorectomy-RRO — OTHER
    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure
  • Risk-Reducing Salpingo-Oophorectomy-RRSO — OTHER
    complete questionnaires, standard-of-care laparoscopy to check the abdominal area before the assigned procedure

Study Details

This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence

Key Dates

Start date
May 10, 2022
Status verified
Apr 2026
Primary completion
Dec 26, 2026
Completion
Dec 26, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: Risk-Reducing Salpingectomy-RRS
    Can help to lower the risk of ovarian cancer with a delayed removal of 1.
  • Other: Risk-Reducing Oophorectomy-RRO
    Can help to lower the risk of ovarian cancer removing both fallopian tubes.
  • Other: Risk-Reducing Salpingo-Oophorectomy-RRSO
    Can help to lower the risk of ovarian cancer as well as the standard-of-care risk-reducing procedure involving the removal of the fallopian tubes and ovaries (risk-reducing salpingo-oophorectomy-RRSO)

Primary Outcome Measure

To evaluate the non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers. [ Time Frame: through study completion, an average of 15 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Colleen Feltmate
[email protected]
Colleen Feltmate (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Jamie N Bakkum-Gamez, MD
[email protected]
Jamie N Bakkum-Gamez, MD (PRINCIPAL_INVESTIGATOR)
WU St LouisSt LouisMissouri63130
Andrea Hagemann, MD
Andrea Hagemann, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Kara Long-Roche, MD
[email protected]
Kara Long-Roche, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Health SystemNew YorkNew York10029
Stephanie Blank, MD
[email protected]
Stephanie Blank, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Sarah Kim, MD
[email protected]
Sarah Kim, MD (PRINCIPAL_INVESTIGATOR)
Lyndon Baines Johnson GeneralHoustonTexas77026
Roni Wilke, MD
[email protected]
Roni Wilke, MD (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Roni Wilke, MD
[email protected]
713-822-4502
University of WashingtonSeattleWashington98195
Barbara Norquist, MD
[email protected]
Barbara Norquist, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Dana Farber Cancer Institute· Boston, MAMayo Clinic· Rochester, MNWU St Louis· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYMount Sinai Health System· New York, NYUniversity of Pennsylvania· Philadelphia, PA

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