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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30+
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Uterine lavage, or a wash of the womb

    Diagnostic test

    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.

  • Blood sample

    Diagnostic test

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

  • Pap smear

    Diagnostic test

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Pelvic Mass Cohort (cohort #1)3 interventions
Group B: BRCA1/2 Carriers Cohort (cohort #2)3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment through to pathology results post-surgery (usually same day)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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