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Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer
NCT04794322 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Uterine lavage, or a wash of the womb
- DIAGNOSTIC_TEST Blood sample
- DIAGNOSTIC_TEST Pap smear
Study Locations (6)
Maryland
- Anne Arundel Health System — Annapolis
- Johns Hopkins University School of Medicine — Baltimore
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
California
- Kaiser Permanente - San Francisco — San Francisco
Massachusetts
- Massachusetts General Hospital — Boston
Washington
- The Swedish Hospital — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-04-13 |
| Est. Completion | 2028-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04794322
The ClinicalTrials.gov registry entry for NCT04794322 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Ovarian Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Uterine lavage, or a wash of the womb is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04794322 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Maryland, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04794322 about?
NCT04794322 is a clinical study titled "Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer". 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 wheth...
What is the current status of trial NCT04794322?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2020-04-13. Estimated completion is 2028-08-31.
What conditions does trial NCT04794322 study?
This clinical trial studies the following conditions: Ovarian Neoplasms, Fallopian Tube Neoplasms, Stage III Ovarian Cancer AJCC v8, High Grade Ovarian Serous Adenocarcinoma, Ovarian Epithelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04794322?
The interventions under investigation include: Uterine lavage, or a wash of the womb (DIAGNOSTIC_TEST), Blood sample (DIAGNOSTIC_TEST), Pap smear (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04794322?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04794322 being conducted?
This trial has 6 study locations across Arkansas, California, Maryland, Massachusetts, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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