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Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

RecruitingNAAges 18 Years - anyFemaleJessica D. St. Laurent, MD
NCT07220239 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Hap

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📋 Eligibility rules (as published)
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)
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What it tests

  • Menstrual cup use
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Where

1 site
Dana-Farber Cancer Institute
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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