Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07220239

Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

Led by Jessica D. St. Laurent, MD · Updated on 2026-03-02

25

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

Sponsors

J

Jessica D. St. Laurent, MD

Lead Sponsor

D

Dana-Farber Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 (called the endometrium) to help screen for endometrial cancer. This is especially important for women who have a higher chance of getting this cancer, such as those with a genetic condition called Lynch syndrome. Main Questions the Study Will Answer: 1. Can a menstrual cup collect enough uterine lining (endometrial tissue) for doctors to examine under a microscope? 2. Are the samples from the menstrual cup as useful for diagnosis as samples taken using the usual method (called an endometrial biopsy or EMB)? 3. Is using a menstrual cup at home easy, effective, and comfortable for participants? 4. Can scientists grow small lab models of the uterus (called organoids) from the menstrual cup samples and from biopsy samples? What Will Happen in the Study: * Participants will use a menstrual cup at home to collect menstrual blood. * They will also have a standard endometrial biopsy done by a healthcare provider. * After both collections, participants will fill out a short survey about how comfortable and easy it was to use the menstrual cup. What the Study Will Measure: * Feasibility: How well participants are able to use the menstrual cup and send in the sample. * Sample Quality: Whether the menstrual cup collects enough good-quality tissue for testing, and how it compares to biopsy samples. * Participant Experience: How women feel about using the menstrual cup, based on the survey. * Lab Testing: Whether researchers can successfully grow endometrial organoids from both types of samples. Why This Study Matters: If this method works, it could offer a gentler, more convenient way for women to get checked for endometrial cancer-especially those who need regular screening. It could also make it easier to collect samples for research and improve early detection of cancer.

CONDITIONS

Official Title

Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals over the age of 18
  • Menstruating
  • Lynch syndrome carrier with a pathogenic or likely pathogenic variant in MLH1, MSH2, MSH6, PMS2, or EPCAM (for main study)
  • Planned screening endometrial biopsy (for main study)
  • Ability to give consent (for main study)
Not Eligible

You will not qualify if you...

  • Levonorgestrel intrauterine device (IUD) in place or removed within 30 days before sample collection
  • Prior endometrial ablation
  • Prior history of endometrial cancer or endometrial intraepithelial neoplasia (for pre-pilot study)
  • History of germline pathologic variant in MLH1, MSH2, MSH6, PMS2, or EPCAM (for pre-pilot study)
  • Known allergy to menstrual cup material (silicone)
  • Current pregnancy (for main study)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

J

Jessica D St. Laurent, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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