Menstrual cup for early detection of endometrial cancer in Lynch syndrome
Official title: Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients
Run by Brigham and Women's Hospital · NCT07220239 · Data updated 2026-11-12
This project will test whether using a menstrual cup can collect uterine lining samples that help detect early endometrial cancer in menstruating people who carry Lynch syndrome gene changes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 20, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07220239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Menstruating adults with a pathogenic or likely pathogenic Lynch syndrome variant (MLH1, MSH2, MSH6, PMS2, or EPCAM) who are scheduled for an endometrial biopsy and can consent.
✕Probably not a fit
People who are postmenopausal, currently pregnant, have a recent levonorgestrel IUD, prior endometrial ablation or cancer, or a known silicone allergy are excluded and unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This two-part pilot at Dana-Farber first runs a small pre-pilot (n=5) to optimize collection and organoid methods, then a main pilot (n=20) enrolling menstruating Lynch syndrome carriers undergoing planned endometrial biopsy. Participants collect menstrual fluid at home with a menstrual cup and submit it for pathological review and laboratory processing, then undergo routine clinician-performed endometrial biopsy for direct comparison. The study compares sample adequacy and diagnostic concordance between cup-collected fluid and biopsy tissue and attempts to grow organoids from both sample types. Patient and provider questionnaires will track feasibility, comfort, and satisfaction.
Why it matters
Potential benefit: If successful, this could provide a less invasive, at-home way to detect early endometrial changes in high-risk individuals and potentially reduce the need for invasive biopsies.
How similar studies have gone: Small prior studies have shown menstrual blood can contain endometrial cells and biomarkers, but using menstrual cup-collected samples for diagnostic comparison and for organoid generation in Lynch syndrome is largely novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Jessica D St. Laurent, MD — Brigham and Women's Hospital
- Study coordinator: Jessica D St. Laurent, MD
- Email: jdstlaurent@bwh.harvard.edu
- Phone: 857-215-1892
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.