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Could a menstrual cup replace painful biopsies for cancer screening?

NCT ID NCT07220239

Diagnosis Sponsor: Jessica D. St. Laurent, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a menstrual cup can collect enough uterine tissue to screen for endometrial cancer, especially in women with Lynch syndrome who are at higher risk. About 25 participants will use a menstrual cup at home and also have a standard biopsy, then compare the samples. If it works, this could be a simpler, less painful way to catch cancer early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Pre-pilot study Inclusion criteria: * Individuals over the age of 18 * Menstruating Exclusion criteria: * 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) Main Study Inclusion criteria * 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 criteria: * 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)

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Conditions

The condition(s) this trial relates to.

Colorectal Neoplasms, Hereditary Nonpolyposis endometrium neoplasm Lynch syndrome endometrial cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early detection of cancer Endometrial cancer Lynch syndrome Screening

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.