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SCREEN-CUP

Menstrual Cup for Endometrial Cancer Detection in Lynch Syndrome

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What is being tested

Menstrual cup use

Device
Who is being recruted

Colonic Diseases
+24

+ Colorectal Neoplasms, Hereditary Nonpolyposis
+ Digestive System 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, 2025Actual 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 
NCT07220239
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colonic Diseases
Colorectal Neoplasms, Hereditary Nonpolyposis
Digestive System Diseases
Digestive System Neoplasms
Female Urogenital Diseases and Pregnancy Complications
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Intestinal Diseases
Intestinal Neoplasms
Metabolic Diseases
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Nutritional and Metabolic Diseases
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Colorectal Neoplasms
Endometrial Neoplasms
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Female Urogenital Diseases
Urogenital Diseases
Genital 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

Show More Criteria

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

Show More Criteria

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

Menstrual cup use in menstruating women to collect menstrual fluid with the aim to 1) compare the histology to endometrial biopsy samples from the same patient, to 2) investigate the feasibility and clinical utiliy of a menstrual cup use as a screening method for endometrial cancer and to 3) generate organoids from the menstrual cup samples
Study Objectives
Primary Objectives

A pathologist will evaluate the menstrual cup-based sample and record its adequacy for pathological evaluation using a questionnaire with binary responses.
Secondary Objectives

Participants self-report to questions on overall participant satisfaction with menstrual cup collection for endometrial screening with 5 answer possiblities ranging from "very satisfied" to "very dissatisfied".

Successful organoid generation from menstrual cup sampleswill be assessed by viability assays after 5 days of culture and immunofluorescence imaging to compare cell composition.

Successful organoid generation from EMB samples will be assessed by viability assays after 5 days of culture and immunofluorescence imaging to compare cell composition.

Provider self-report on question regarding satisfaction of menstrual cup collection for endometrial cancer screening within this study setting with 5 answer possiblities ranging from "very satisfied" to "very dissatisfied".

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 InstituteBoston, United StatesSee the location
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One Study Center