Using a uterine wash and a blood protein test to find ovarian cancer early
Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study
This project will try to find tumor DNA in a uterine wash plus protein markers in blood to detect ovarian or fallopian tube cancer in women having surgery for a suspected ovarian growth or BRCA1/2 carriers having risk-reducing surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 30 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 6 sites (Little Rock, Arkansas and 5 other locations) |
| Trial ID | NCT04794322 on ClinicalTrials.gov |
What this trial studies
The study collects a uterine lavage (a wash of the womb) and blood samples before surgery and compares test results with the final pathology after surgery. Two sequencing approaches (Duplex sequencing of TP53 and Haloplex sequencing of an 18-gene panel) will be used on uterine lavage DNA, while protein biomarker assays will be run on blood at separate labs, with small aliquots sent to four sites for analysis. The design is prospective and PRoBE-compliant, enrolling a primary cohort of about 200 preoperative participants (expected ~50 cancers) and a second cohort of ~50 BRCA1/2 carriers (expected a small number of microscopic cancers). Cases are defined by pathologic invasive epithelial ovarian/fallopian tube cancer and compared with controls who have benign disease or no cancer identified at surgery.
Who should consider this trial
Good fit: Women age 30 or older with an intact uterus who are scheduled for surgery or diagnostic laparoscopy for a suspected ovarian/fallopian tube mass, or BRCA1/2 mutation carriers scheduled for risk-reducing salpingo-oophorectomy, are the intended participants.
Not a fit: People without an intact uterus, those already diagnosed with cancer by prior tissue/cytology, individuals under 30, or anyone unable to provide the required uterine lavage or blood samples would not be eligible and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable earlier, less invasive detection of ovarian or fallopian tube cancers by combining uterine-wash tumor DNA and blood protein markers.
How similar studies have performed: Previous small studies have shown promise detecting tumor DNA from uterine or cervical samples (notably TP53 alterations), but the approach remains experimental and not yet validated for routine early detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Little Rock, Arkansas and 5 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
- Kaiser Permanente - San Francisco — San Francisco, California, United States (Active_not_recruiting)
- Anne Arundel Health System — Annapolis, Maryland, United States (Recruiting)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- The Swedish Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Jackie Dahlgren
- Email: jdahlgre@fredhutch.org
- Phone: 206 667 3438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.