Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJessica D. St. Laurent, MD

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Individuals over the age of 18

Menstruating

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Menstrual cup use

    Device

    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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Pilot study armOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of samples considered adequate for pathologic evaluation

A pathologist will evaluate the menstrual cup-based sample and record its adequacy for pathological evaluation using a questionnaire with binary responses.

Time frame
Postprocedural (7-14 days after study visit #2)

Secondary outcomes

1

Overall participant satisfaction with menstrual cup collection for endometrial screening.

Participants self-report to questions on overall participant satisfaction with menstrual cup collection for endometrial screening with 5 answer possibilities ranging from "very satisfied" to "very dissatisfied".

Time frame
Periprocedural (on day of study visit #2)
2

Successful endometrial organoid generation from menstrual cup sample

Successful organoid generation from menstrual cup samples will be assessed by viability assays after 5 days of culture and immunofluorescence imaging to compare cell composition.

Time frame
Postprocedural (5-7 days after study visit #2)
3

Successful endometrial organoid generation from endometrial biopsy sample (EMB).

Successful organoid generation from EMB samples will be assessed by viability assays after 5 days of culture and immunofluorescence imaging to compare cell composition.

Time frame
Postprocedural (5-7 days after study visit #2)
4

Provider satisfaction of menstrual cup collection for endometrial cancer screening within this study setting

Provider self-report on question regarding satisfaction of menstrual cup collection for endometrial cancer screening within this study setting with 5 answer possiblities ranging from "very satisfied" to "very dissatisfied".

Time frame
Through study completion, an average of 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jessica D. St. Laurent, MD

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

Dana-Farber Cancer Institute

Collaborator