NCT07220239Recruiting
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 11 Aug 2025
- Start date
- 20 Nov 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Jessica D. St. Laurent, MD
- Diseases
- Endometrial cancer
- NCT number
- NCT07220239
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 20 Nov 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- History of germline pathologic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM
- Known allergy against menstrual cup material (silicone)
- Main Study Inclusion criteria
- Known allergy against menstrual cup material (silicone)
Age
- Individuals over the age of 18
Other
- LS carrier with a pathogenic or likely pathogenic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM
- Planned screening EMB
- Menstruating
- Ability to give consent
- Current pregnancy
Who the study is looking for
- Individuals over the age of 18
- Menstruating
Criteria the registry did not label
- Pre-pilot study
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.