Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Jessica D. St. Laurent, MD
Study ID
NCT07220239
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Menstrual cup use — DEVICE
    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 utility of a menstrual cup use as a screening method for endometrial cancer and to 3) generate organoids from the menstrual cup samples

Study Details

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.

Key Dates

Start date
Nov 20, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

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

Primary Outcome Measure

Proportion of samples considered adequate for pathologic evaluation [ Time Frame: Postprocedural (7-14 days after study visit #2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Jessica D St. Laurent, MD
[email protected]
4135635543
Laura Wollborn, MD
[email protected]
617
Jessica D St. Laurent, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MA

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