Recruiting

Menstrual Cup

Sponsor:

Jessica D. St. Laurent, MD

Code:

NCT07220239

Conditions

Endometrial Cancer

Lynch Syndrome

Screening

Early Detection of Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Menstrual cup use

Study Details

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.

Conditions

Endometrial Cancer

Lynch Syndrome

Screening

Early Detection of Cancer

Study ID

NCT07220239

Start date

Nov 20, 2025

Status verified date

Jun, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Pilot study arm

Single arm study: Intervention includes use of a mentrual cup to collect menstrual fluid

Interventions

Menstrual cup use

Menstrual cup use in menstruating women to collect menstrual fluid with the aim to 1) compare the histology to endometrial biopsy samples from the same patient, to 2) investigate the feasibility and clinical utility of a menstrual cup use as a screening method for endometrial cancer and to 3) generate organoids from the menstrual cup samples

Primary outcome measure

  • Proportion of samples considered adequate for pathologic evaluation [ Time Frame: Postprocedural (7-14 days after study visit #2) ]

Central Contacts and Locations

Central contacts

Jessica D St. Laurent, MD

857-215-1892jdstlaurent@bwh.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jessica D St. Laurent, MD

4135635543jdstlaurent@bwh.harvard.edu

Laura Wollborn, MD

617lwollborn@bwh.harvard.edu

Principal Investigator:

Jessica D St. Laurent, MD

More Information

Sponsor

Jessica D. St. Laurent, MD

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Endometrial Cancer
  • Lynch Syndrome
  • Screening
  • Early detection
  • Organoids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jessica D. St. Laurent, MD on 2026-06-10.