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.
> 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
Prior tubal ligation
Prior history of known ovarian or endometrial cancer
Single group
Uterine Lavage
Other interventionUndergo uterine lavage
Archive Sample
Procedure/SurgeryAncillary studies
Survey Administration
Other interventionAncillary 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).
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.
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.
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.
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