Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Location contact
Barbara Norquist, MD
PRINCIPAL_INVESTIGATOR
Intake Coordinators
CONTACT
Intake Coordinators
CONTACT
Not yet recruiting
NCT Number: NCT07772869
Uterine Lavage to Detect Ovarian Cancer Risk
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.
Not yet recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
OUTLINE:
Patients undergo uterine lavage prior to their standard of care (SOC) risk-reduction surgery and uterine lavage samples undergo molecular analysis on study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Uterine Lavage
OtherUndergo uterine lavage
Other names: Irrigation, Wash
Archive Sample
ProcedureAncillary studies
Survey Administration
OtherAncillary studies
Primary outcomes
-
TP53 mutation burden (MB)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Intake Coordinators
CONTACT
Intake Coordinators
CONTACT
Sponsors and collaborators
Lead sponsor
University of Washington
Other
Registry information
Official study title
Collection of Uterine Lavage in High-Risk Patients as a Potential Biomarker for Ovarian Cancer Risk
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Aug 19, 2026
- Registry last updated
- Aug 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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