Menstrual flow as a non-invasive source of endometrial organoids.
Tereza Cindrova-Davies, Xiaohui Zhao, Kay Elder...
https://pubmed.ncbi.nlm.nih.gov/34140633/Actively Recruiting
Led by Jessica D. St. Laurent, MD · Updated on 2026-06-10
25
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying a non-invasive method to collect uterine lining samples using a menstrual cup to help screen for endometrial cancer, particularly in women with Lynch syndrome, a genetic condition increasing cancer risk. This pilot trial aims to see if menstrual cup samples can replace or complement the usual endometrial biopsy method and to explore if lab-grown uterine models can be created from these samples. Participants will use a menstrual cup at home during menstruation to collect uterine lining fluid. They will also undergo a standard endometrial biopsy performed by a healthcare provider. The study consists of a pre-pilot phase with 5 menstruating women and a main pilot phase involving 20 women with Lynch syndrome undergoing routine biopsy screening. Both sample types will be compared for quality and usefulness, and participant and provider satisfaction will be assessed. During the study, participants will complete surveys about their experience using the menstrual cup. Researchers will evaluate how well participants collect and send samples, the quality of tissue obtained, and the success of growing organoids from the samples. The main outcome measured is the adequacy of samples for pathological evaluation. The trial will monitor participant comfort and feasibility over about one year, including follow-up assessments after sample collection.
CONDITIONS
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
J
Jessica D St. Laurent, MD
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Jessica D. St. Laurent, MD
Lead Sponsor
Dana-Farber Cancer Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Menstrual cup collection | Standard surveillance |
|---|---|---|
| what it is | A device-based method where a menstrual cup collects menstrual fluid for cellular and histological analysis and organoid generation | The usual surveillance includes clinician‑performed endometrial biopsy or prompt evaluation if symptoms such as abnormal bleeding occur |
| role in trial | Investigational diagnostic approach evaluated in a single‑group pilot to assess feasibility and adequacy | Not performed in the trial; represents routine clinical surveillance outside the study |
| primary use | To collect endometrial cells non‑invasively during menstruation to compare histology with biopsy and generate organoids | To sample endometrial tissue for pathologic evaluation when indicated |
| how it is given or performed | Participant self‑collects menstrual fluid using a menstrual cup during menstruation | Clinician‑performed endometrial biopsy or evaluation following symptoms |
| evidence status | Early feasibility study; diagnostic adequacy and organoid success under evaluation | Clinically validated method for endometrial sampling for pathology and diagnosis |
| important risks | Risks not yet established in this context | Potential for discomfort, bleeding or cramping during biopsy |
| important limitations | Unproven sensitivity and adequacy compared to standard biopsy; only tested in menstruating LS carriers | Invasive procedure; may require clinic visit and may not detect early changes in asymptomatic periods |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - One-time collection during the study period
Participants use a menstrual cup at home during menstruation to collect uterine lining fluid and also undergo a standard endometrial biopsy performed by a healthcare provider.
1 visit for endometrial biopsy and sample submission
Duration - Up to 1 year
Participants complete surveys about comfort and ease of menstrual cup use. Researchers evaluate sample quality, participant satisfaction, and attempt to grow uterine organoids from collected samples.
Periodic questionnaires and assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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Tereza Cindrova-Davies, Xiaohui Zhao, Kay Elder...
https://pubmed.ncbi.nlm.nih.gov/34140633/Sylvia C Hewitt, Mackenzie J Dickson, Nicole Edwards...
https://pubmed.ncbi.nlm.nih.gov/37810883/Russell W Jenkins, Amir R Aref, Patrick H Lizotte...
https://pubmed.ncbi.nlm.nih.gov/29101162/Jessica D. St. Laurent, MD
Lead Sponsor
Dana-Farber Cancer Institute
Collaborating Sponsor