Developing a Test for the Detection of Ovarian Cancer

The study aims to develop a test for early detection of ovarian cancer using DNA from a
growth involving the ovary found in a washing of the uterus (womb), and proteins found in the
blood. The samples of the wash and the blood will be taken before surgery. After surgery,
doctors will determine whether the participant had ovarian cancer or a benign disease of the
ovaries. The tests of the washings and the blood will be examined to see how much the
participants with ovarian cancer can be separated from the participants with a benign ovarian
disease by the tests. Small amounts from the washing and the blood samples will be sent to
four sites for analysis.

Statistical analyses of these data will compare tumor DNA found in the washing of the uterus
with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find
tests that are mostly positive for cases of ovarian cancer and mostly negative for patients
with benign disease. It is hoped that if the tests work for participants with symptoms of the
disease that these tests will also work when testing women who have no symptoms. A new study
would be needed to see if the tests worked in this situation. If the tests work, this could
lead to increasing the number of cases detected in early stage disease and decreasing the
number of cases detected in late stage disease. If this change in late stage is large, it
will likely reduce deaths due to ovarian cancer.

Intervention

Blood sample, Pap smear, Uterine lavage, or a wash of the womb

Condition

Ovarian Neoplasms, Ovarian Epithelial Carcinoma, Fallopian Tube Neoplasms, High Grade Ovarian Serous Adenocarcinoma, Stage I Ovarian Cancer, Stage II Ovarian Cancer, Stage III Ovarian Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA1 Ovarian Cancer AJCC v8, Stage IIIA2 Ovarian Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8

Investigators

Christos Patriotis, PhD, Monica Jones, MD, Charles Drescher, MD, Rebecca Stone, MD, Amy Bregar, MD, Christine Garcia, MD, Kristin Zorn, MD

See list of participating sites