Using a uterine wash and a blood protein test to find ovarian cancer early

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States 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
• Kaiser Permanente - San Francisco
  San Francisco, California, United States Active not recruiting

Study contacts

• Study coordinator: Jackie Dahlgren
• Email: jdahlgre@fredhutch.org
• Phone: 206 667 3438

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.