Menstrual Cup for Endometrial Cancer Detection

(SCREEN-CUP Trial)

Recruiting at 1 trial location

Overseen By Jessica D St. Laurent, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jessica D. St. Laurent, MD

Must not be taking: Levonorgestrel IUD

Disqualifiers: Pregnancy, Endometrial ablation, Cancer, others

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

Compensation: Varies

Number of Visits: 2

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a menstrual cup can serve as a non-invasive method to collect samples from the uterus for endometrial cancer screening. The researchers aim to determine if samples collected with the menstrual cup match the quality of those from a standard endometrial biopsy. Women who are menstruating and have conditions like Lynch syndrome, which increase the risk of endometrial cancer, might be suitable candidates. Participants will use a menstrual cup at home and then undergo a traditional biopsy to compare results. If successful, this method could simplify and enhance the comfort of cancer screening. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could lead to more comfortable cancer screening methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a Levonorgestrel IUD, it must not be in place or removed within the last 30 days before sample collection.

What prior data suggests that using a menstrual cup for endometrial cancer detection is safe?

Research has shown that menstrual cups provide a safe and comfortable method for collecting samples from the uterus. Studies indicate they are less invasive and more comfortable for diagnosing endometrial cancer compared to traditional methods like biopsies. No major reports of problems have emerged when using menstrual cups for this purpose, suggesting participants tolerate them well. Overall, menstrual cups offer a promising and safe alternative for collecting uterine samples, especially for those requiring regular screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a menstrual cup for endometrial cancer detection because it offers a non-invasive and convenient way to collect menstrual fluid for analysis. Unlike traditional methods that might require surgical procedures or biopsies, this innovative approach allows for easy, at-home sample collection. This method has the potential to make endometrial cancer detection more accessible, cost-effective, and less intimidating for women, leading to earlier diagnoses and better outcomes.

What evidence suggests that using a menstrual cup is effective for endometrial cancer detection?

Research has shown that menstrual cups might offer a promising method for collecting samples to diagnose endometrial cancer. Studies have found menstrual cups to be less invasive and more comfortable than traditional biopsies. The menstrual fluid collected can be measured accurately, aiding in early cancer detection. This trial will explore using a menstrual cup for sample collection, particularly benefiting women with conditions like Lynch syndrome, who require frequent screenings. Overall, early studies suggest that using a menstrual cup could simplify and improve the detection of endometrial cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Jessica D St. Laurent, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for women with Lynch syndrome, which increases the risk of endometrial and colorectal cancer. Participants should be willing to use a menstrual cup at home and undergo an endometrial biopsy by a healthcare provider. The study aims to include those who need regular screening for early detection of cancer.

Inclusion Criteria

I am currently menstruating.

I carry a genetic change linked to Lynch syndrome.

Planned screening EMB

Exclusion Criteria

Known allergy against menstrual cup material (silicone)

Current pregnancy

I have a levonorgestrel IUD or had it removed in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-pilot study

Pre-pilot study including 5 menstruating females providing a one-time menstrual cup-based endometrial collection for organoid generation and pathological evaluation.

Not specified

1 visit (in-person)

Main pilot study

Prospective feasibility study with 20 female LS carriers providing a one-time menstrual cup-based endometrial collection and endometrial biopsy specimen.

Not specified

1 visit (in-person)

Follow-up

Participants are monitored for sample adequacy, participant satisfaction, and organoid generation success.

7-14 days

What Are the Treatments Tested in This Trial?

Interventions

• Menstrual Cup

Trial Overview The study tests if a menstrual cup can effectively collect uterine lining samples as an alternative to traditional biopsies for detecting endometrial cancer in high-risk women. It will compare the ease of use, sample quality, and participant comfort between the menstrual cup method and standard biopsy.

How Is the Trial Designed?

Group I: Pilot study arm Experimental Treatment 1 Intervention

Single arm study: Intervention includes use of a mentrual cup to collect menstrual fluid

Who Is Running the Clinical Trial?

Jessica D. St. Laurent, MD

Lead Sponsor

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220239

Menstrual Cup for Early Endometrial Cancer Detection in ... Study Goal: This pilot study wants to find out if using a menstrual cup can be a good, non-invasive way to collect samples from the lining of the uterus ...

2. pharmacytimes.com pharmacytimes.com/view/study-menstrual-cups-an-effective-more-comfortable-method-of-diagnosis-for-endometrial-cancer

Study: Menstrual Cups an Effective, More Comfortable ... Menstrual cups may provide a novel, less invasive, and more comfortable approach to the diagnosis of endometrial cancer.

3. patlynk.com patlynk.com/trial/NCT07220239

Menstrual Cup for Endometrial Cancer Detection in Lynch ... This clinical trial explores a new way to collect and test samples from inside the uterus, specifically targeting women with Lynch Syndrome, ...

4. withpower.com withpower.com/trial/phase-endometrial-neoplasms-10-2025-d5c44

Menstrual Cup for Endometrial Cancer Detection ... It will compare the ease of use, sample quality, and participant comfort between the menstrual cup method and standard biopsy.

5. sciencedirect.com sciencedirect.com/science/article/pii/S266657192400032X

The composition of menstrual fluid, its applications, and ... Menstrual fluid can be collected relatively noninvasively using a menstrual cup, and its components can be directly measured, demonstrating a reproducible ...

6. brighamandwomens.org brighamandwomens.org/cancer/every-day-feminine-products-and-their-link-to-cancer

Everyday Feminine Products: What's Safe, What's Hype, ... St. Laurent is leading a novel study that uses menstrual cups to help detect endometrial cancer earlier—especially for people with a high genetic risk due to ...