Uterine Lavage to Detect Ovarian Cancer Risk

NCT07772869 — Not applicable, Recruiting, 75 participants, University of Washington

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Collection of Uterine Lavage in High-Risk Patients as a Potential Biomarker for Ovarian Cancer Risk

Registry	NCT07772869
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, screening
Enrollment	75 (Estimated)
Sponsor	University of Washington (Other)
Conditions	BRCA Hereditary Ovarian Carcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
Interventions	Uterine Lavage, Archive Sample, Survey Administration (Other, procedure)
Dates	start 2026-09-03, primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-08-19, last updated 2026-09-14
Locations	1 site in United States

-Summary

This clinical trial develops a non-surgical approach using uterine lavage samples to screen for progression to ovarian cancer in high-risk patients carrying BRCA mutations. Women with inherited mutations in the BRCA1 and BRCA2 genes (BRCA carriers) have a much higher lifetime risk of developing ovarian cancer. Currently there are no effective ovarian cancer screening or early detection tests for BRCA carriers. Uterine lavage is a procedure that uses saline to rinse and collect cells from the fallopian tube. Molecular analysis of these samples may help proactively detect genetic alterations that are indicative of progression to ovarian cancer in women with BRCA mutations.

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+Detailed description

OUTLINE:

Patients undergo uterine lavage prior to their standard of care (SOC) risk-reduction surgery and uterine lavage samples undergo molecular analysis on study.

+Arms and interventions

Arm	Type	Interventions	Description
Screening (uterine lavage)	Experimental	Other: Uterine Lavage; Procedure: Archive Sample; Other: Survey Administration	Patients undergo uterine lavage prior to their standard of care risk-reduction surgery and uterine lavage samples undergo molecular analysis on study.

Uterine Lavage (Other), also known as Irrigation, Wash: Undergo uterine lavage
Archive Sample (Procedure): Ancillary studies
Survey Administration (Other): Ancillary studies

+Outcome measures

Primary outcomes

TP53 mutation burden (MB) [Up to 2 years]: Will compare TP53 MB in lavages of women with and without serous tubal intraepithelial carcinoma/high grade serous carcinoma (HGSC).
Correlation of TP53 mutation burden (MB) in lavages with known HGSC risk factors [Up to 2 years]: Will correlate TP53 MB in lavages with known HGSC risk factors (age, CA125, parity, age of menarche, and use of oral contraceptives) using univariate and multivariate linear models.
Comparison of TP53 mutation burden (MB) in lavages between BRCA carriers with and without multiple TP53 pathogenic clones in fallopian tube tissue [Up to 2 years]: TP53 MB in lavages will also be compared between BRCA carriers with and without multiple TP53 pathogenic clones in fallopian tube tissue.
Correlation of TP53 mutation burden (MB) in fallopian tubes and uterine lavages with the presence and number of cell clusters with positive immunostaining for TP53 in fallopian tubes [Up to 2 years]: Will assess the correlation of TP53 MB in fallopian tubes and uterine lavages with the presence and number of cell clusters with positive immunostaining for TP53 in fallopian tubes.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* > 18 years of age
* Have a pathogenic BRCA1 or BRCA2 germline variant
* Planned risk-reduction surgery
* Presence of uterus and at least one fallopian tube

Exclusion Criteria:

* Prior tubal ligation
* Prior history of known ovarian or endometrial cancer

+Locations (1)

Facility	City	Country	Status
Fred Hutch/University of Washington Cancer Consortium	Seattle, Washington	United States	Recruiting

+Investigators

Barbara Norquist, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium