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

This study aims to develop a new test for early detection of ovarian cancer. Researchers are looking at DNA found in a uterine lavage (a wash of the womb) and proteins in blood samples. These samples will be collected before surgery. After surgery, doctors will determine if you have ovarian cancer or a benign (non-cancerous) ovarian condition. The study will then compare the results from the uterine lavage and blood tests to see how well they can identify ovarian cancer. You may be eligible if you are a woman aged 30 or older with an intact uterus, scheduled for surgery for suspected ovarian/fallopian tube cancer, or a known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing surgery.

Study design
This is an observational study involving 250 participants. It is designed to collect samples before surgery and then compare them to the surgical diagnosis.
What's involved
You would undergo a uterine lavage during surgery, two blood draws (one required, one optional) up to 31 days before surgery, and a standard Pap smear.
Compensation
Not stated in the trial record.
Follow-up
Biomarkers will be measured from enrollment through to pathology results post-surgery (usually the same day).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04794322

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

Recruiting
Not specifiedAges 30+Observational
Massachusetts General Hospital
~250 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:Uterine lavage, or a wash of the wombBlood samplePap smear

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Genomic biomarkers assessing mutations and methylation of tumor DNA, and protein biomarkers measured as the concentration of a protein in pg/mL, both types of biomarkers measured in the collected biospecimens.
Measured over From enrollment through to pathology results post-surgery (usually same day)

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

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmBRCA1 Gene

Where it's being run

6 sites across 5 states
Maryland2
Arkansas1
California1
Massachusetts1
Washington1

Study leadership

  • Christos Patriotis, PhD · STUDY_DIRECTOR · National Cancer Institute (NCI)

Who to contact

Jackie Dahlgren
[email protected]
206 667 3438
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer
Inability to provide informed consent
Age less than 30 years
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)
Prior history of known ovarian or endometrial cancer
Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin
History of untreated high-grade cervical dysplasia (CIN3)
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.
Currently pregnant
Known Lynch syndrome

What this trial measures

  • Genomic biomarkers assessing mutations and methylation of tumor DNA, and protein biomarkers measured as the concentration of a protein in pg/mL, both types of biomarkers measured in the collected biospecimens.From enrollment through to pathology results post-surgery (usually same day)

    Biomarkers that distinguish between ovarian cancer and benign ovarian disease