Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis

This research study is a Feasibility Study, to try to evaluate whether or not culdocentesis
can detect tumor associated cell free DNA. Although this is the first time investigators are
using this type of procedure to detect cell free DNA, culdocentesis is not a new procedure.
It used to be done routinely in the past to examine pelvic fluid. The investigator's goal is
to develop a test to detect ovarian cancer in women before they develop any signs or symptoms
of the disease. Currently, there is no screening test for ovarian cancer.

This study uses a technique called "culdocentesis" to detect DNA released by ovarian cancer
cells into pelvic fluid. During culdocentesis, a small needle is inserted through the vagina
into an empty space between the uterus and the rectum called the "cul-de-sac." Fluid is
withdrawn from this space and sent for analysis. Culdocentesis is a technique that has been
used for many years to examine pelvic fluid and determine its composition, but it has not
previously been studied as a technique for examining cell-free DNA to detect ovarian cancer.
The investigators suspect that this may be a useful way to detect cell-free DNA from ovarian
cancer cells because the ovaries are very close to the cul-de-sac space.

In this study, the investigators will compare our ability to detect cell-free DNA in fluid
from the cul-de-sac with our ability to detect cell-free DNA from a vaginal swab (similar to
a Pap smear), a blood test, and in the tissue specimens collected at the time of surgery. The
investigators are hoping to learn from this study whether developing a cell-free DNA test to
screen for ovarian cancer involving culdocentesis would be an effective strategy.

Inclusion Criteria:

- Female

- Age ≥ 18

- Able to give informed consent

- Scheduled for surgery at Brigham and Women's Hospital for known or highly suspected
Stage III or IV ovarian cancer (i.e. elevated CA-125 with a pelvic mass, ascites, and
carcinomatosis)

- Post-menopausal or negative urine and/or blood pregnancy test

- Measurable disease on preoperative imaging

Exclusion Criteria:

- Male

- Age < 18

- Unable to give informed consent

- Not planned for surgical intervention

- Active malignancy other than ovarian cancer

- Prior bilateral tubal ligation or hysterectomy (as this would prevent
chromopertubation)

- Known or suspected active pelvic infection

- Pregnancy

- No measurable disease or suspected Stage I or II ovarian cancer on preoperative
imaging