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

Recruiting now

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04794322

Run by

Massachusetts General Hospital

People needed

250

Starts

2020-04-13

Expected to finish

2028-08-31

Last updated by the study team

2025-09-16

Who can join

Age: 30 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Inability to obtain the minimum amount of uterine lavage sample
• At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm/dL)
• Prior history of known ovarian or endometrial cancer
• Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin
• History of untreated high-grade cervical dysplasia (CIN3)
• History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.
• Currently pregnant
• Known Lynch syndrome

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Anne Arundel Health System — Annapolis, Maryland, United States (enrolling)
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• The Swedish Hospital — Seattle, Washington, United States (enrolling)
• Kaiser Permanente - San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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