About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)
Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian/fallopian tube cancer
Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy
Disqualifiers
Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer
Inability to provide informed consent
Age less than 30 years
Inability to obtain the minimum amount of blood
Trial population
Cohorts will be selected from patients scheduled for ovarian disorder-related surgeries across six sites: Massachusetts General Hospital in Boston, Massachusetts; Luminis Health System in Annapolis, Maryland; Johns Hopkins University School of Medicine in Baltimore, Maryland; Kaiser Permanente - San Francisco in San Francisco, California; the Swedish Medical Center in Seattle, Washington; and the University of Arkansas for Medical Sciences in Little Rock, Arkansas.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Uterine lavage, or a wash of the womb
Diagnostic testUterine 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.
Blood sample
Diagnostic testParticipants undergo two blood draws (one required, one optional) up to 31 days before surgery
Pap smear
Diagnostic testParticipants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.
Treatment groups
Trial outcomes
Primary outcomes
Genomic biomarkers assessing mutations and methylation of tumor DNA, and protein biomarkers measured as the concentration of a protein in pg/mL, both types of biomarkers measured in the collected biospecimens.
Biomarkers that distinguish between ovarian cancer and benign ovarian disease
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Johns Hopkins University
Collaborator
Fred Hutchinson Cancer Center
Collaborator
Anne Arundel Health System Research Institute
Collaborator
University of Arkansas
Collaborator
National Cancer Institute (NCI)
Collaborator
Kaiser Permanente
Collaborator
McGill University
Collaborator
M.D. Anderson Cancer Center
Collaborator
Swedish Medical Center
Collaborator
Early Detection Research Network
Collaborator