Recruiting

SCREEN-CUPMenstrual Cup for Endometrial Cancer Detection in Lynch Syndrome

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What is being tested

Menstrual cup use

Device
Who is being recruted

Urogenital Diseases+24

+ Genital Diseases

+ Colonic Diseases

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorJessica D. St. Laurent, MD
Study ContactJessica D St. Laurent, MD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: November 20, 2025

Actual date on which the first participant was enrolled.

This clinical trial explores a new way to collect and test samples from inside the uterus, specifically targeting women with Lynch Syndrome, a genetic condition that increases the risk of endometrial cancer. The research investigates whether using a menstrual cup to collect these samples can be a good alternative to the traditional method, which involves a more invasive endometrial biopsy. This study is vital because it could offer a less uncomfortable and more convenient method for women with Lynch Syndrome to undergo regular screenings, potentially catching cancer signs earlier and improving overall care. Participants in the study will use a menstrual cup to collect a sample of their menstrual fluid, which will then be analyzed and compared to a sample obtained through the usual biopsy method. The researchers will look at the quality of the samples and how well they can be used to grow organoids, which are small, lab-grown versions of human tissues. The study also assesses how satisfied the women and healthcare providers are with this new method, gathering their feedback through surveys. This information could help determine if the menstrual cup method is a feasible and preferred option for regular cancer screenings in the future.

Official TitleMenstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients 
Principal SponsorJessica D. St. Laurent, MD
Study ContactJessica D St. Laurent, MD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesColonic DiseasesColorectal Neoplasms, Hereditary NonpolyposisDigestive System DiseasesDigestive System NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Neoplasms, FemaleIntestinal DiseasesIntestinal NeoplasmsMetabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryNutritional and Metabolic DiseasesUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsColorectal NeoplasmsEndometrial NeoplasmsGenetic Diseases, InbornDNA Repair-Deficiency DisordersFemale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
LS carrier with a pathogenic or likely pathogenic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM

Planned screening EMB

Ability to give consent

Individuals over the age of 18

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7 exclusion criteria prevent from participating
Prior history of endometrial cancer or endometrial intraepithelial neoplasia

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

Current pregnancy

Prior history of endometrial cancer

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Dana-Farber Cancer Institute

Boston, United StatesSee the location
Recruiting
One Study Center