NCT04794322Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 19 Feb 2021
- Start date
- 13 Apr 2020
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT04794322
What you commit to
- Study type: Observational
- Planned participants: 250
- From 13 Apr 2020 to the primary completion date, 31 Aug 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of known ovarian or endometrial cancer
- 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.
Other illness
- Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer
- Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin
- History of untreated high-grade cervical dysplasia (CIN3)
- Known Lynch syndrome
Age
- Age less than 30 years
Other
- Inability to provide informed consent
- 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)
- Currently pregnant
Who the study is looking for
- 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
Age in the registry: 30 years to - · Sex: Female · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anne Arundel Health System Coordinator of this site? Confirm its status | Annapolis | United States | Recruiting |
| Johns Hopkins University School Of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Kaiser Permanente-San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Active, not recruiting |
| The Swedish Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.