RecruitingRecruiting
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
NCT07220239 · Brigham and Women's Hospital
In plain English
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Official title
Menstrual Cup-based Endometrial Collection as an Alternative to Endometrial Biopsy in Lynch Syndrome Patients
About this study
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome (SCREEN-CUP) The study entails two parts that will be conducted one after each other.
1. Pre-pilot study Pre-pilot study including 5 menstruating females who will provide a one-time menstrual cup-based endometrial collection for the generation of organoids and for a pathological evaluation of endometrial specimen from menstrual fluid.
After optimizing the study protocol in the pre-pilot study period, the main study will be conducted.
2. Main pilot study Prospective feasibility study including 20 female Lynch syndrome (LS) carriers undergoing annual endometrial biopsy for endometrial cancer surveillance or suspected endometrial pathology will provide a one-time menstrual cup-based endometrial collection and endometrial biopsy specimen. One study aim is to evaluate the comparability and quality of the menstrual cup-based endometrial collection with the EMB sample from the same patient. For the second study aim, endometrial sample collected with the menstrual cup and EMB will be used and compared for organoid generation. Patient satisfaction and feasibility will be monitored through patient and provider questionnaires.
Eligibility criteria
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)
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-20
Estimated completion: 2026-09
Last updated: 2026-03-02
Interventions
Device: Menstrual cup use
Primary outcomes
- • Proportion of samples considered adequate for pathologic evaluation (Postprocedural (7-14 days after study visit #2))
Sponsor
Jessica D. St. Laurent, MD · other
With: Dana-Farber Cancer Institute
Contacts & investigators
ContactJessica D St. Laurent, MD · contact · jdstlaurent@bwh.harvard.edu · 857-215-1892
InvestigatorJessica D St. Laurent, MD · principal_investigator, Brigham and Women's Hospital
All locations (1)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States