Recruiting

Ovarian Cancer Screening

Sponsor:

University of Washington

Code:

NCT07772869

Conditions

BRCA Hereditary Ovarian Carcinoma

Fallopian Tube High Grade Serous Adenocarcinoma

Ovarian High Grade Serous Adenocarcinoma

Primary Peritoneal High Grade Serous Adenocarcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Uterine Lavage

Archive Sample

Survey Administration

Study Details

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.

Conditions

BRCA Hereditary Ovarian Carcinoma

Fallopian Tube High Grade Serous Adenocarcinoma

Ovarian High Grade Serous Adenocarcinoma

Primary Peritoneal High Grade Serous Adenocarcinoma

Study ID

NCT07772869

Start date

Sep 3, 2026

Status verified date

Aug, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Screening (uterine lavage)

Patients undergo uterine lavage prior to their standard of care risk-reduction surgery and uterine lavage samples undergo molecular analysis on study.

Interventions

Uterine Lavage

Undergo uterine lavage

Archive Sample

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • TP53 mutation burden (MB) [ Time Frame: Up to 2 years ]
  • Correlation of TP53 mutation burden (MB) in lavages with known HGSC risk factors [ 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 [ 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 [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Intake Coordinators

206-616-3913swisherlabrc@uw.edu

Intake Coordinators

206-616-2532swisherlabrc@uw.edu

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Intake Coordinators

206-616-3913swisherlabrc@uw.edu

Intake Coordinators

206-221-6648swisherlabrc@uw.edu

Principal Investigator:

Barbara Norquist, MD

More Information

Sponsor

University of Washington

Last update posted

Sep 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by University of Washington on 2026-09-14.