NCT07772869

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Jun 2028

First Submitted

Initial submission to the registry

August 10, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

September 3, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.7 years

First QC Date

August 10, 2026

Last Update Submit

September 11, 2026

Conditions

BRCA Hereditary Ovarian CarcinomaFallopian Tube High Grade Serous AdenocarcinomaOvarian High Grade Serous AdenocarcinomaPrimary Peritoneal High Grade Serous Adenocarcinoma

Outcome Measures

Primary Outcomes (4)

  • TP53 mutation burden (MB)

    Will compare TP53 MB in lavages of women with and without serous tubal intraepithelial carcinoma/high grade serous carcinoma (HGSC).

    Up to 2 years

  • 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.

    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

    TP53 MB in lavages will also be compared between BRCA carriers with and without multiple TP53 pathogenic clones in fallopian tube tissue.

    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

    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.

    Up to 2 years

Study Arms (1)

Screening (uterine lavage)

EXPERIMENTAL

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

Other: Uterine LavageProcedure: Archive SampleOther: Survey Administration

Interventions

Uterine LavageOTHER

Undergo uterine lavage

Also known as: Irrigation, Wash
Screening (uterine lavage)
Archive SamplePROCEDURE

Ancillary studies

Screening (uterine lavage)
Survey AdministrationOTHER

Ancillary studies

Screening (uterine lavage)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • Prior tubal ligation
  • Prior history of known ovarian or endometrial cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Interventions

Therapeutic Irrigation

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Barbara Norquist, MD

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Intake Coordinators

CONTACT

206-616-3913swisherlabrc@uw.edu

Intake Coordinators

CONTACT

206-616-2532swisherlabrc@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 19, 2026

Study Start

September 3, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

September 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)