Actively Recruiting

Age: 30Years +
FEMALE
NCT04794322

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

Led by Massachusetts General Hospital · Updated on 2025-09-16

250

Participants Needed

6

Research Sites

437 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

J

Johns Hopkins University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 30Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Has intact uterus with no history of uterine ablation, tubal ligation, or bilateral salpingectomy
  • Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian or fallopian tube cancer (Cohort 1)
  • Women with known BRCA1 or BRCA2 mutation scheduled for risk-reducing salpingo-oophorectomy (Cohort 2)
Not Eligible

You will not qualify if you...

  • Current diagnostic tissue or cytology test positive for ovarian or any cancer
  • Unable to provide informed consent
  • Age less than 30 years
  • Unable to provide required blood samples
  • Unable to provide required uterine lavage sample
  • At risk from blood draw (e.g., hemophilia, serious anemia with hemoglobin less than 8.0 gm/dL)
  • Prior history of ovarian or endometrial cancer
  • Cancer treatment within past year for cancer that spread beyond its origin (excluding hormonal therapy)
  • Untreated high-grade cervical dysplasia (CIN3)
  • Treated high-grade cervical dysplasia (CIN3) with abnormal Pap smear within past year; if no recent Pap smear, must have normal Pap smear before surgery
  • Currently pregnant
  • Known Lynch syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

2

Kaiser Permanente - San Francisco

San Francisco, California, United States, 94115

Active, Not Recruiting

3

Anne Arundel Health System

Annapolis, Maryland, United States, 21401

Actively Recruiting

4

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21218

Actively Recruiting

5

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

6

The Swedish Hospital

Seattle, Washington, United States, 98122

Actively Recruiting

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Research Team

J

Jackie Dahlgren

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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