Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
Jessica D. St. Laurent, MD · with Dana-Farber Cancer Institute · NCT07220239
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 25
- US sites recruiting
- 1
- Study start
- November 20, 2025
- Record last updated
- June 10, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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
- Can a menstrual cup collect enough uterine lining (endometrial tissue) for doctors to examine under a microscope?
- Are the samples from the menstrual cup as useful for diagnosis as samples taken using the usual method (called an endometrial biopsy or EMB)?
- Is using a menstrual cup at home easy, effective, and comfortable for participants?
- 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.
Being studied: Menstrual cup use
Conditions: Endometrial Cancer; Lynch Syndrome; Screening; Early Detection of Cancer
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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)
Recruiting US locations
Dana-Farber Cancer Institute
Boston, MA 02215
Site contact: Jessica D St. Laurent, MD · 4135635543 · jdstlaurent@bwh.harvard.edu
Study contacts (from the official record)
- Jessica D St. Laurent, MD · 857-215-1892 · jdstlaurent@bwh.harvard.edu
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