Status:
ACTIVE_NOT_RECRUITING
Prophylactic Salpingectomy With Delayed Oophorectomy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Ovarian Carcinoma
Eligibility:
FEMALE
30-47 years
Phase:
NA
Brief Summary
The goal of this clinical research study is to compare ovarian cancer screening, risk-reducing salpingo-oophorectomy (RRSO), and prophylactic salpingectomy with delayed oophorectomy (PSDO). The safety...
Detailed Description
This study has 3 options: ovarian cancer screening, PSDO, and RRSO. You may choose which study group you want to take part in. However, you must let the researchers know what your choice is before any...
Eligibility Criteria
Inclusion
- Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as \>/= 12 months of amenorrhea.
- Women must be at least 30 and less than 48 years of age.
- Candidate for surgery and willing to undergo two surgical procedures (if chooses the PSDO arm).
- Patient choosing PSDO or RRSO must desire permanent sterilization.
- Presence of at least one fallopian tube. Prior tubal ligation is allowed.
- Participants may have a personal history of non-ovarian malignancy, but must be without evidence of disease at enrollment and the patient must have completed treatment (including surgery, chemotherapy, or radiotherapy) \> 3 months prior to enrollment (other than non-melanoma skin cancer). Current or past SERM or aromatase inhibitor use is allowed.
- Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care.
- Willingness to return to the enrolling site for ovarian cancer screening during the study period.
Exclusion
- Postmenopausal women or women \< 30 or \>/= 48 years of age.
- Women without a documented BRCA mutation.
- Women with a history of ovarian, fallopian tube, or primary peritoneal cancer.
- Women currently undergoing cancer treatment or with a known active cancer. History of malignancy is allowed as long as the patient has completed treatment \> 3 months prior to enrollment.
- Medical comorbidities making surgery unsafe as determined by the patient's surgeon.
- Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.
- Women who are pregnant. Patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta HCG, or best judgement of the investigator. Pregnancy testing is not required per protocol to determine study eligibility.
- Women desiring future fertility except in the screening arm of the trial.
- Women whose most recent CA125 or transvaginal ultrasound is abnormal. A history of abnormal CA125 or ultrasound is allowed, as long as the most recent testing is normal.
- Inability to provide informed consent.
- Inability to read or speak English.
Key Trial Info
Start Date :
August 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01907789
Start Date
August 26 2013
End Date
December 31 2030
Last Update
October 27 2025
Active Locations (2)
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1
NorthShore University Health System
Evanston, Illinois, United States, 60201
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030