NCT07772869 · University of Washington
Uterine Lavage to Detect Ovarian Cancer Risk
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Uterine Lavage
Undergo uterine lavage
PROCEDURE
Archive Sample
Ancillary studies
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations