Prophylactic Salpingectomy With Delayed Oophorectomy

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 testing for the study begins. The 3 study groups are described in detail
below.

GROUP 1: OVARIAN CANCER SCREENING:

Study Visits:

For this group, there is no testing required before starting the study. If you agree to be in
Group 1, the following tests and procedures will be performed:

- You will have a physical exam, including a pelvic exam.

- You will have a transvaginal ultrasound (ultrasound inside the vagina) to look at your
ovaries and fallopian tubes.

- Blood (about 2 tablespoons) will be drawn to measure your CA125 levels. This test is
used to screen for ovarian cancer.

- You will complete a questionnaire about your quality of life. This should take up to 15
minutes.

Every 6 months for up to 3 years:

- You will have a physical exam, including a pelvic exam.

- Blood (about 2 tablespoons) will be drawn for CA-125 testing.

- You will have a transvaginal ultrasound to look at your ovaries and fallopian tubes.

At the end of Years 1, 2, and 3, you will complete the quality-of-life questionnaire.

All of your test results will be discussed with you. If any of your test results are
abnormal, the study doctor may ask you to have additional testing, which may include CA-125
testing, ultrasound, and/or a computed tomography (CT) scan or magnetic resonance imaging
(MRI). If the results show cancer, the study doctor will refer you to a gynecologic
oncologist (a doctor for women's cancer) and/or recommend that you have your ovaries and
fallopian tubes removed.

Length of Study:

You may have study visits for up to 3 years. You will be taken off study early if you develop
cancer or if you are unable to follow study directions.

At any time or preferably at the end of 3 years, you will have the option to cross over and
choose one of the treatment options (Group 2 or 3).

Follow-Up:

One (1) time a year after your last study visit for as long as needed, the study staff will
contact you by phone, e-mail, or letter to ask if you have had any changes in your medical
history. If you are called, the calls should last about 5 minutes.

GROUP 2: FALLOPIAN TUBE REMOVAL WITH DELAYED OVARY REMOVAL (PSDO):

Salpingectomy:

If you are found to be eligible to take part in this study in Group 2, the study doctor will
discuss the salpingectomy surgery with you in detail, including the risks and possible
benefits. You will be asked to sign a surgical consent form. After that, the salpingectomy
will be scheduled.

Most patients have salpingectomy performed as an outpatient procedure. This means that you
will likely go home the day of your surgery. If the study doctor plans to have you stay
overnight in the hospital for any reason, it will be discussed with you.

During the surgery, the inside of your abdomen will be looked at and both of your fallopian
tubes will be removed. If the study doctor finds anything during the surgery that may be
cancerous, a tissue sample or a complete ovary will be removed during surgery and tested. If
cancer is found, a gynecologic oncologist would perform your cancer surgery.

Post-Salpingectomy Follow-Up:

The study staff will call you 1 day and 1 week after surgery to ask how you are doing. The
calls should last about 5 minutes.

One (1) month after surgery:

- You will have a physical exam, including an exam of your surgical incisions (wounds).

- You will complete the quality-of-life questionnaire.

The pathology (tissue) results from your surgery will be discussed with you at either the
1-week phone call or the 1-month visit. If the results show cancer, the study doctor will
refer you to a gynecologic oncologist.

Ovarian Cancer Screening Period:

Every 6 months or until your delayed oophorectomy after the salpingectomy:

- You will have a physical exam, including a pelvic exam.

- Blood (about 2 tablespoons) will be drawn for CA-125 testing.

- You will have a transvaginal ultrasound to look at your ovaries.

You will complete the quality-of-life questionnaire 1 time a year until 1 year after your
delayed oophorectomy.

Pre-Oophorectomy Testing:

After the 3-year screening period, you will have a pre-oophorectomy visit. The following
tests and procedures will be performed:

- You will have a physical exam, including a pelvic exam.

- Blood (about 2 tablespoons) will be drawn for routine tests and CA-125 testing.

- You will have a transvaginal ultrasound to look at your ovaries, if this has not been
done in the last 6 months.

- You will complete the quality-of-life questionnaire, if this has not been done in the
last 6 months.

- You may have other tests performed if the study doctor thinks it is needed.

Oophorectomy:

If your pre-surgical testing is normal, the study doctor will discuss the planned surgery
with you in detail, including the risks and possible benefits. You will be asked to sign a
surgical consent form. After that, the oophorectomy will be scheduled.

Most patients have oophorectomy performed as an outpatient procedure. This means that you
will likely go home the day of your surgery. If the study doctor plans to have you stay
overnight in the hospital for any reason, it will be discussed with you.

During the surgery, the inside of your abdomen will be looked at and both of your ovaries
will be removed. If the study doctor finds anything during the surgery that may be cancerous,
a tissue sample will be removed during surgery and tested.

Post-Oophorectomy Follow-Up:

The study staff will call you 1 day and 1 week after surgery to ask how you are doing.

One (1) month after surgery:

- You will have a physical exam, including an exam of your surgical incisions.

- You will complete the quality-of-life questionnaire.

The pathology results from your surgery will be discussed with you at either the 1-week phone
call or the 1-month visit. If the results show cancer, the study doctor will refer you to a
gynecologic oncologist.

At 6 months and 1 year after surgery, you will complete the quality-of-life questionnaire.

At 1 year after surgery:

- You will have a physical exam, including a pelvic exam.

- Blood (about 2 tablespoons) will be drawn for CA-125 testing.

All of your test results will be discussed with you. If any of your test results are
abnormal, the study doctor may ask you to have additional testing, which may include CA-125
testing, ultrasound, and/or a CT scan or MRI. If the results show cancer, the study doctor
will refer you to a gynecologic oncologist.

Length of Study:

You will have study visits until 1 year after your oophorectomy. You will be taken off study
early if you develop cancer or if you are unable to follow study directions.

Follow-Up:

One (1) time a year after your last study visit for as long as needed, the study staff will
contact you by phone, e-mail, or letter to ask if you have had any changes in your medical
history.

GROUP 3: REMOVAL OF FALLOPIAN TUBES AND OVARIES AT THE SAME TIME (RRSO):

RRSO:

If you are found to be eligible to take part in this study in Group 3, the study doctor will
discuss the surgery with you in detail, including the risks and possible benefits. You will
be asked to sign a surgical consent form. After that, the RRSO will be scheduled.

Most patients have RRSO performed as an outpatient procedure. This means that you will likely
go home the day of your surgery. If the study doctor plans to have you stay overnight in the
hospital for any reason, it will be discussed with you.

During the surgery, the inside of your abdomen will be looked at and both of your ovaries and
fallopian tubes will be removed. If the study doctor finds anything during the surgery that
may be cancerous, a tissue sample will be removed during surgery and tested.

The pathology results from your surgery will be discussed with you at either the 1-week phone
call or the 1-month visit. If the results show cancer, the study doctor will refer you to a
gynecologic oncologist.

Post-Surgery Follow-Up:

The study staff will call you 1 day and 1 week after surgery to ask how you are doing.

One (1) month after surgery:

- You will have a physical exam, including an exam of your surgical incisions.

- You will complete the quality-of-life questionnaire.

The pathology results from your surgery will be discussed with you at either the 1-week phone
call or the 1-month visit. If the results show cancer, the study doctor will refer you to a
gynecologic oncologist.

At 6 months and 1 year after surgery, you will complete the quality-of-life questionnaire.

At 1 year after surgery:

- You will have a physical exam, including a pelvic exam.

- Blood (about 2 tablespoons) will be drawn to measure your CA-125.

All of your test results will be discussed with you. If any of your test results are
abnormal, the study doctor may ask you to have additional testing, which may include CA-125
testing, ultrasound, and/or a CT scan or MRI. If the results show cancer, the study doctor
will refer you to a gynecologic oncologist.

Length of Study:

You will have study visits for up to 1 year after surgery. You will be taken off study early
if you develop cancer or if you are unable to follow study directions.

Follow-Up:

One (1) time a year after your last study visit for as long as needed, the study staff will
contact you by phone, e-mail, or letter to ask if you have had any changes in your medical
history.

This is an investigational study. At this time, the only known method that may lower your
risk of ovarian cancer is to have both of your ovaries and fallopian tubes removed (RRSO).
Screening for ovarian cancer does not lower the risk that you will develop cancer. PSDO has
not previously been studied and may not lower your ovarian cancer risk. PSDO is currently
being used for research purposes only.

Up to 80 women will take part in this multicenter study. Up to 60 will be enrolled at MD
Anderson.

Inclusion Criteria:

1. Premenopausal women with a documented BRCA1 or BRCA2 mutation. Menopause is defined as
>/= 12 months of amenorrhea.

2. Women must be at least 30 and less than 48 years of age.

3. Candidate for surgery and willing to undergo two surgical procedures (if chooses the
PSDO arm).

4. Patient choosing PSDO or RRSO must desire permanent sterilization.

5. Presence of at least one fallopian tube. Prior tubal ligation is allowed.

6. 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.

7. Willingness to return to the enrolling site for any surgical procedures including
pre-operative and post-operative care.

8. Willingness to return to the enrolling site for ovarian cancer screening during the
study period.

Exclusion Criteria:

1. Postmenopausal women or women < 30 or >/= 48 years of age.

2. Women without a documented BRCA mutation.

3. Women with a history of ovarian, fallopian tube, or primary peritoneal cancer.

4. 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.

5. Medical comorbidities making surgery unsafe as determined by the patient's surgeon.

6. Prior bilateral salpingectomy. Prior unilateral salpingectomy is allowed.

7. 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.

8. Women desiring future fertility except in the screening arm of the trial.

9. 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.

10. Inability to provide informed consent.

11. Inability to read or speak English.