Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

This study is exploring if using a menstrual cup can be a simple, non-invasive way to collect samples from the lining of the uterus (endometrium) for early detection of endometrial cancer. This is especially important for women with Lynch syndrome, a genetic condition that increases their risk. Researchers want to see if the samples collected by a menstrual cup are good enough for doctors to examine under a microscope and if they are as useful as samples taken by the usual method (endometrial biopsy). The study will also look at how easy and comfortable it is for participants to use the menstrual cup at home. You may be able to join if you are a menstruating woman over 18 years old.

Study design: This is an interventional pre-pilot study planning to enroll 25 menstruating women. It will compare samples collected by menstrual cup to those from endometrial biopsies.
What's involved: Participants will provide a one-time menstrual cup-based endometrial collection. Some participants will also undergo an endometrial biopsy.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, adequacy of samples for pathologic evaluation, is measured 7-14 days after the second study visit.

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Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

Recruiting

NAAges 18+InterventionalScreening

Jessica D. St. Laurent, MD

~25 participants

Updated 2026-06-10 on ClinicalTrials.gov

What's tested:Menstrual cup use

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Proportion of samples considered adequate for pathologic evaluation

Measured over Postprocedural (7-14 days after study visit #2)

Conditions

Endometrial Cancer

Lynch Syndrome

Screening

Early Detection of Cancer

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

Jessica D St. Laurent, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Jessica D St. Laurent, MD

[email protected]

857-215-1892

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals over the age of 18

Menstruating

LS carrier with a pathogenic or likely pathogenic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM

Individuals over the age of 18

Planned screening EMB

Menstruating

Ability to give consent

Exclusion

Levonorgestrel intrauterine device (IUD) in situ or removed within the last 30 days prior to sample collection

Patients with prior endometrial ablation

Prior history of endometrial cancer or endometrial intraepithelial neoplasia

History of germline pathologic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM

Known allergy against menstrual cup material (silicone)

Current pregnancy

Levonorgestrel IUD in situ or removed within the last 30 days prior to sample collection

Patients with prior endometrial ablation

Prior history of endometrial cancer

Known allergy against menstrual cup material (silicone)

What this trial measures

Proportion of samples considered adequate for pathologic evaluationPostprocedural (7-14 days after study visit #2)
A pathologist will evaluate the menstrual cup-based sample and record its adequacy for pathological evaluation using a questionnaire with binary responses.

Trialytics