Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients

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.

Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome