NCT07220239 Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
| NCT ID | NCT07220239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jessica D. St. Laurent, MD |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-11-20 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Jessica D St. Laurent, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT07220239 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07220239 currently recruiting?
Yes, NCT07220239 is actively recruiting participants. Contact the research team at jdstlaurent@bwh.harvard.edu for enrollment information.
Where is the NCT07220239 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07220239 clinical trial?
NCT07220239 is sponsored by Jessica D. St. Laurent, MD. The principal investigator is Jessica D St. Laurent, MD at Brigham and Women's Hospital. The trial plans to enroll 25 participants.
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