Status:
RECRUITING
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
Lead Sponsor:
Jessica D. St. Laurent, MD
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Endometrial Cancer
Lynch Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 en...
Detailed Description
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 includi...
Eligibility Criteria
Inclusion
- Pre-pilot study
- Inclusion criteria:
- Individuals over the age of 18
- Menstruating
- Exclusion criteria:
- 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 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)
Exclusion
Key Trial Info
Start Date :
November 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07220239
Start Date
November 20 2025
End Date
September 1 2026
Last Update
November 25 2025
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215