Menstrual cup for early detection of endometrial cancer in Lynch syndrome
Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07220239 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.