RecruitingNCT04794322

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

Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study


Sponsor

Massachusetts General Hospital

Enrollment

250 participants

Start Date

Apr 13, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a new test for ovarian cancer using uterine lavage — a gentle flushing of the uterus — to collect cells that may contain cancer markers from nearby ovarian or fallopian tube cancers. Researchers hope this could become a less invasive early detection method, especially for high-risk women. **You may be eligible if...** - You have an intact uterus (no prior ablation, tubal ligation, or removal of both fallopian tubes) - You are scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian or fallopian tube cancer, OR - You are a known BRCA1 or BRCA2 carrier scheduled for risk-reducing removal of ovaries and tubes **You may NOT be eligible if...** - You have already been diagnosed with ovarian cancer or any cancer through biopsy or tissue tests - You have had procedures that affect the uterus (ablation, bilateral salpingectomy, or tubal ligation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUterine 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_TESTBlood sample

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

DIAGNOSTIC_TESTPap smear

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


Locations(6)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente - San Francisco

San Francisco, California, United States

Anne Arundel Health System

Annapolis, Maryland, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Swedish Hospital

Seattle, Washington, United States

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NCT04794322


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