A Study to Compare Two Surgical Procedures in Individuals with BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer (SOROCk- NRG-CC008)
Recruiting
35-50 years
Female
Phase
N/A
1 Location
Brief description of study
The purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed childbearing. In this study, the removal of fallopian tubes will be compared to the removal of fallopian tubes and ovaries. The study will also examine what factors go into deciding which surgery to have and symptoms after surgery caused by lack of estrogen due to ovary removal.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: ovarian cancer, BRCA1, Salpingectomy, Salpingo-Oophorectomy
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Age: Between 35 Years - 50 Years
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Gender: Female
Inclusion Criteria:
- Individuals 35-50 years of age, inclusive
- Patients who are undergoing risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted
- At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and fallopian tube (with fimbria not removed) are present
- Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required
- Patients may be premenopausal or menopausal
- Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future
Exclusion Criteria:
- Individuals with a history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
- Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
- Patients medically unfit for the planned surgical procedure
- Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days
- An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary)
- An abnormal CA-125 is defined as a level > 50 U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal individuals who are current users of oral contraceptives. An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals.
Updated on
01 Aug 2024.
Study ID: 848702
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