Menstrual flow as a non-invasive source of endometrial organoids.
Tereza Cindrova-Davies, Xiaohui Zhao, Kay Elder...
https://pubmed.ncbi.nlm.nih.gov/34140633Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID07220239
Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients
Led by Jessica D. St. Laurent, MD · Updated on 2026-03-02
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jessica D. St. Laurent, MD
Lead Sponsor
D
Dana-Farber Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a menstrual cup can be used as a non-invasive way to collect samples from the lining of the uterus (endometrium) to help screen for endometrial cancer. This study focuses on women with Lynch syndrome, a genetic condition that increases the risk of developing this cancer. The trial aims to determine if menstrual cup samples are adequate for diagnosis compared to the usual endometrial biopsy, and if organoids can be grown from these samples for research. The study has two parts. First, a pre-pilot with 5 menstruating women will collect menstrual fluid once using the menstrual cup to develop lab models and evaluate tissue samples. Then, a main pilot study with 20 female Lynch syndrome carriers will collect menstrual fluid using the menstrual cup and also undergo a standard endometrial biopsy. Participants will complete surveys on comfort and ease of use. Researchers will compare sample quality and success of organoid growth between the two collection methods. Participants will use the menstrual cup at home to collect menstrual blood and attend a visit for the endometrial biopsy. Researchers will assess how well the menstrual cup works, participant satisfaction, and if organoids can be grown from the samples. The main measure is the proportion of samples suitable for pathological evaluation. The study also monitors provider satisfaction and participant experience, with follow-up extending up to one year. Total involvement includes sample collection, biopsies, surveys, and sample testing.
CONDITIONS
Brief Title
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Individuals over the age of 18
- Female and menstruating
- For the main study: Lynch syndrome carrier with a pathogenic or likely pathogenic germline variant in MLH1, MSH2, MSH6, PMS2, or EPCAM
- Planned endometrial biopsy screening for the main study
- Ability to give consent
You will not qualify if you...
- Levonorgestrel intrauterine device (IUD) currently in place or removed within the last 30 days
- Prior endometrial ablation
- Prior history of endometrial cancer or endometrial intraepithelial neoplasia (for pre-pilot) or endometrial cancer (for main study)
- History of germline pathologic variants in MLH1, MSH2, MSH6, PMS2, or EPCAM (for pre-pilot)
- Known allergy to menstrual cup material (silicone)
- Current pregnancy (for main study)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Implementation
Duration - One-time use during menstrual cycle
Participants use a menstrual cup during menstruation to collect menstrual fluid for comparison with endometrial biopsy samples, feasibility assessment, and organoid generation.
1 study visit for menstrual cup use and endometrial biopsy (in-person)
Long-term Monitoring
Duration - Up to 1 year
Participant satisfaction and provider feedback on menstrual cup use for endometrial cancer screening are collected over time.
Questionnaires conducted through study completion
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
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Research Team
J
Jessica D St. Laurent, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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Published Research Related To This Trial
Ex Vivo Profiling of PD-1 Blockade Using Organotypic Tumor Spheroids.
Russell W Jenkins, Amir R Aref, Patrick H Lizotte...
https://pubmed.ncbi.nlm.nih.gov/29101162From cup to dish: how to make and use endometrial organoid and stromal cultures derived from menstrual fluid.
Sylvia C Hewitt, Mackenzie J Dickson, Nicole Edwards...
https://pubmed.ncbi.nlm.nih.gov/37810883