BRCA Hereditary Ovarian Carcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
Conditions
Brief 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.
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.
Interventions
OTHERUterine Lavage
Undergo uterine lavage
PROCEDUREArchive Sample
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTIntake Coordinators
PRINCIPAL_INVESTIGATORBarbara Norquist, MD
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed