75 Participants NeededMy employer runs this trial

Uterine Lavage for Ovarian Cancer Risk Detection

IC
Overseen ByIntake Coordinators
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks a new method to detect ovarian cancer early in women with BRCA gene mutations, who face a higher risk of developing this cancer. The procedure, called uterine lavage, rinses and collects cells from the fallopian tube for analysis. The trial seeks women with BRCA1 or BRCA2 mutations who still have their uterus and at least one fallopian tube and are planning risk-reduction surgery. The goal is to determine if this method can identify genetic changes that might lead to cancer. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in early cancer detection.

What prior data suggests that this uterine lavage method is safe for ovarian cancer risk detection?

Research has shown that uterine lavage, which uses a saltwater solution to rinse and collect cells from the fallopian tube, is safe. In a study with 93 participants, nearly all procedures succeeded, and most patients found the process easy. The study also found that uterine lavage gathered enough cells for analysis in every patient, crucial for cancer detection. Importantly, no major side effects or safety issues were reported, indicating that the procedure is well-tolerated. This makes uterine lavage a promising non-surgical option for ovarian cancer screening in high-risk patients.12345

Why are researchers excited about this trial?

Researchers are excited about uterine lavage for ovarian cancer risk detection because it offers a non-invasive approach to potentially identifying cancer risk earlier than current methods, which often rely on imaging and blood tests. This technique involves washing the uterus and analyzing the fluid for molecular markers that could indicate the presence or risk of ovarian cancer. Unlike standard procedures, uterine lavage could provide a more direct and localized assessment of risk, helping to identify individuals who may benefit from early intervention.

What evidence suggests that uterine lavage is effective for ovarian cancer risk detection in BRCA carriers?

Research has shown that uterine lavage, a procedure involving the rinsing and collection of cells from the fallopian tube, might help detect early signs of ovarian cancer in women with BRCA1 or BRCA2 gene mutations. These mutations significantly increase the risk of ovarian cancer. In this trial, participants will undergo uterine lavage before their standard risk-reduction surgery, and researchers will perform molecular analysis on the collected samples. Although direct evidence on the effectiveness of uterine lavage for this purpose remains limited, the goal is to identify genetic changes in cells that could signal the onset of cancer. This early detection method aims to identify potential cancer development early, which is crucial for those at high risk. Initial findings suggest that studying these cells might provide valuable information about cancer risk.678910

Who Is on the Research Team?

BN

Barbara Norquist, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for women who carry BRCA1 or BRCA2 gene mutations, which put them at higher risk for ovarian cancer. Participants should not have a current diagnosis of ovarian cancer and must be able to undergo the uterine lavage procedure.

Inclusion Criteria

I am over 18 years old.
I have a uterus and at least one fallopian tube.
I have a BRCA1 or BRCA2 gene mutation.
See 1 more

Exclusion Criteria

I have had my fallopian tubes tied (tubal ligation).
I have had ovarian or endometrial cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Uterine Lavage Procedure

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

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the uterine lavage procedure

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Uterine Lavage

Trial Overview

Researchers are testing if collecting and analyzing cells from the uterus using a saline rinse (uterine lavage) can help detect early signs of ovarian cancer in high-risk women. The study also uses surveys and archived samples.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Screening (uterine lavage)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28126327/

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Our pilot study proved that ctDNA from ovarian neoplasms can be collected from uterine lavage for diagnostic needs. We revealed precise detection of TP53, BRCA1 ...

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Original Study Uterine and Tubal Lavage for Earlier Cancer ...

In study I, the UtL was carried out successfully in 92 (98.9%) of 93 cases by 16 different gynecologists. It was rated as easy to perform in 84.8% of patients ...