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SCREEN-CUP: Menstrual Cup Screening for Endometrial Cancer in Lynch Syndrome
https://www.facingourrisk.org/research-clinical-trials/study/398
/screen-cup-menstrual-cup-screening-for-endometrial-cancer-in-lynch-syndrome
Clinicaltrials.gov identifier:
NCT07220239 (https://clinicaltrials.gov/show/NCT07220239)
Prevention
Screening study for endometrial cancer
Study Contact Information:
Name: Jessica D St. Laurent, MD
Phone Number: 857-215-1892
Email: [email protected]
About the Study
This study is looking at whether a menstrual cup can be used as a simple, non-invasive way to collect menstrual blood for testing. Researchers want to learn if this method can help detect endometrial (uterine) cancer earlier—especially in people with Lynch syndrome or others at high risk.
Instead of using a traditional endometrial biopsy (which collects tissue from inside the uterus), this study tests whether menstrual blood collected during a period may contain cells that can be used to detect cancer.
What the Study Involves
Participants will be placed into one of two groups:
Group 1
- Provide a one-time menstrual blood sample using a menstrual cup
- Complete questionnaires about their experience using the cup
Group 2
- People with Lynch syndrome who are already planning routine endometrial biopsy
- Provide a menstrual blood sample using a menstrual cup
- Undergo their scheduled endometrial biopsy
- Complete questionnaires about their experience
Researchers will evaluate:
- Feasibility: How easy it is for participants to use the menstrual cup and return samples
- Sample quality: Whether menstrual blood provides enough material for testing and how it compares to biopsy samples
- Participant experience: Comfort and preferences reported in surveys
- Laboratory analysis: Whether samples can be used to grow cells in the lab for further study
This Study is Open To:
Group 1:
- Age 18 or older
- Currently menstruating
- No known Lynch syndrome mutation
Group 2:
- Age 18 or older
- Currently menstruating
- Have a mutation in a Lynch syndrome gene (MLH1, MSH2, MSH6, PMS2, or EPCAM)
- Already receiving or planning routine endometrial biopsy for screening
This Study is Not Open To:
Group 1:
- Prior history of endometrial cancer
- Current or recently removed IUD
- Known Lynch syndrome mutation
Group 2:
- Currently pregnant
- Current or recently removed IUD
- Prior history of endometrial cancer
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of
individuals and families affected by adult hereditary cancers.