Uterine Lavage for Uterine Cancer

Overseen By Rozelle Laquindanum

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Endometrial cancer, Cervical cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new technique, uterine lavage (a procedure to wash out the uterus), can effectively collect cellular samples during gynecologic surgery. By analyzing these samples, researchers hope to gain insights into the cellular makeup, which could be important for future uterine cancer studies. Individuals undergoing gynecologic surgery at Stanford Healthcare with an intact uterus and cervix may be suitable candidates for this study. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could influence future cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this uterine lavage collection catheter is safe?

Research has shown that uterine lavage is generally well-tolerated. In one study, almost all of the 93 patients completed the procedure without major issues, achieving a success rate of 98.9%. Most doctors found it easy to perform. While this does not directly prove safety, the high completion rate and ease suggest it is safe for patients.

The sources provided do not specify side effects or problems. Since this trial focuses on collecting samples rather than safety, it implies that uterine lavage is considered safe enough for this purpose. The study's main goal is to assess the procedure's practicality and analyze the samples, not to test safety directly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Uterine lavage is unique because it offers a new way to gather information about uterine cancer at a cellular level. Unlike traditional treatments that focus on removing or destroying cancer cells, this method is about collecting and analyzing cells during surgery. Researchers are excited about this approach because it could lead to earlier detection and a better understanding of how uterine cancer behaves, potentially opening doors to more targeted and effective treatments in the future.

What evidence suggests that uterine lavage is effective for uterine cancer?

Research has shown that washing the uterus with fluid, known as uterine lavage, can help detect early signs of endometrial cancer. Studies have found that this method can accurately identify genetic changes linked to endometrial cancer. In one study, all women with endometrial cancer exhibited these changes in their uterine lavage fluid before an official diagnosis. This suggests that uterine lavage could detect cancer early, possibly even before symptoms appear. Overall, it appears promising for early screening and detection of endometrial cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

James Ford, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 or older with an intact uterus, cervix, at least one fallopian tube and ovary who are undergoing gynecologic surgery at Stanford Healthcare. Participants must understand the study and agree to it in writing.

Inclusion Criteria

I am having gynecologic surgery with Stanford Healthcare.

I can understand and am willing to sign the consent form.

I have at least one healthy fallopian tube and ovary.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Sample Collection

Participants undergo gynecologic surgery during which uterine lavage samples are collected for molecular and cellular analysis

At time of surgery

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-surgical complications and the effectiveness of sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Uterine Lavage

Trial Overview The trial is testing a new uterine lavage collection catheter on up to 50 patients. It aims to assess its clinical and technical feasibility during gynecologic surgery and analyze the cellular makeup of the collected samples.

How Is the Trial Designed?

Group I: Single Group Experimental Treatment 1 Intervention

Participants undergoing gynecologic surgery who agree to uterine lavage collection intraoperatively for molecular and cellular analysis.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11921509/

Genetic analysis of uterine lavage fluids to identify women ... Endometrial cancer (EC) is the most prevalent cancer of the female genital tract in developed countries and the sixth most common cancer in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10931181/

Recent Advances in Endometrial Cancer Prevention, Early ... Uterine lavage fluid has been shown to have good sensitivity and specificity for endometrial cancer ... Uterine Cancer Statistics ...

3. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002206

Genomic Analysis of Uterine Lavage Fluid Detects Early ... These findings suggest that while NGS-based analysis of uterine lavage can achieve the necessary sensitivity for endometrial cancer screening, ...

4. mountsinai.org mountsinai.org/about/newsroom/2016/endometrial-cancer-mutations-are-detectable-in-uterine-lavage-fluid-before-a-cancer-is-diagnosed

Endometrial Cancer Mutations Are Detectable In Uterine ... In this prospective study of 107 women, 7 were found to have endometrial cancer based upon histopathological evidence and all 7, even those with ...

5. targetedonc.com targetedonc.com/view/analysis-finds-early-endometrial-cancer-mutations-detectable-in-uterine-lavage-fluid

Analysis Finds Early Endometrial Cancer Mutations ... Genomic analysis of uterine lavage fluid detects early endometrial cancers and reveals a prevalent landscape of driver mutations in women ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1028455916300729

Long-term survival outcomes of laparoscopic staging ... The overall survival rates were 94% in 5 years and 92.7% in 20 years. No port-site metastasis was recorded in this study. Conclusions. Patients with endometrial ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02387645

Pilot Study of the Lavage of the Uterine Cavity for ... The current pilot study aims at answering the scientific question, whether exfoliated cells from Endometrium Carcinoma (EC) can be detected in the lavage ...

8. bmcresnotes.biomedcentral.com bmcresnotes.biomedcentral.com/articles/10.1186/s13104-025-07173-8

Genetic analysis of uterine lavage fluids to identify women at ... Clinical data were evaluated by oncologist from the hospital's patient records. Besides histological results, potential clinical risk factors ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6254778/

Uterine and Tubal Lavage for Earlier Cancer Detection ... 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 ...