Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer
Public ClinicalTrials.gov record NCT04794322. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04794322
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 250 participants
Conditions and interventions
Conditions
- 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
Interventions
- Uterine lavage, or a wash of the womb Diagnostic Test
- Blood sample Diagnostic Test
- Pap smear Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 12, 2020
- Primary completion
- Aug 30, 2027
- Completion
- Aug 30, 2028
- Last update posted
- Sep 15, 2025
2020 – 2028
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | Recruiting |
| Kaiser Permanente - San Francisco | San Francisco | California | 94115 | Active, not recruiting |
| Anne Arundel Health System | Annapolis | Maryland | 21401 | Recruiting |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21218 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| The Swedish Hospital | Seattle | Washington | 98122 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04794322, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04794322 live on ClinicalTrials.gov.