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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
75
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
RECRUITINGTP53 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.