Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer

Summary

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.

Conditions

• 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

Interventions

DIAGNOSTIC_TEST

Uterine lavage, or a wash of the womb

Uterine lavage is performed during surgery using a flexible, 3-way balloon tipped catheter. The catheter is inserted through the cervix, the balloon expanded and the uterine cavity lavaged using 10 cc of sterile saline which is collected, processed and stored for later analysis.

DIAGNOSTIC_TEST

Blood sample

Participants undergo two blood draws (one required, one optional) up to 31 days before surgery

DIAGNOSTIC_TEST

Pap smear

Participants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• Fred Hutchinson Cancer Center

  collaborator OTHER

• Anne Arundel Health System Research Institute

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Kaiser Permanente

  collaborator OTHER

• McGill University

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Swedish Medical Center

  collaborator OTHER

• Early Detection Research Network

  collaborator NETWORK

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Christos Patriotis, PhD · National Cancer Institute (NCI)

Eligibility

Min Age

30 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-13

Primary Completion

2027-08-31

Completion

2028-08-31

FDA Device

Yes

Countries

• United States

Study Locations