An interventional study of Uterine Lavage and Archive Sample in BRCA Hereditary Ovarian Carcinoma, Fallopian Tube High Grade Serous Adenocarcinoma and Ovarian High Grade Serous Adenocarcinoma, sponsored by University of Washington. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by University of Washington · Not applicable, Interventional, and Screening
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.
OUTLINE:
Patients undergo uterine lavage prior to their standard of care (SOC) risk-reduction surgery and uterine lavage samples undergo molecular analysis on study.
Exclusion Criteria:
Patients undergo uterine lavage prior to their standard of care risk-reduction surgery and uterine lavage samples undergo molecular analysis on study.
Other: Uterine Lavage · Procedure: Archive Sample · Other: Survey Administration
Undergo uterine lavage
Also known as: Irrigation, Wash
Ancillary studies
Ancillary studies
TP53 mutation burden (MB)
Will compare TP53 MB in lavages of women with and without serous tubal intraepithelial carcinoma/high grade serous carcinoma (HGSC).
Time frame: Up to 2 years
Correlation of TP53 mutation burden (MB) in lavages with known HGSC risk factors
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.
Time frame: Up to 2 years
Comparison of TP53 mutation burden (MB) in lavages between BRCA carriers with and without multiple TP53 pathogenic clones in fallopian tube tissue
TP53 MB in lavages will also be compared between BRCA carriers with and without multiple TP53 pathogenic clones in fallopian tube tissue.
Time frame: Up to 2 years
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
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.
Time frame: Up to 2 years
Plan to share: No
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University of Washington