This clinical trial studies whether menstrual cups can be used for the collection of endometrial samples in Lynch syndrome (LS) patients. Individuals with LS have a higher lifetime risk of developing various cancers, most notably colorectal, endometrial, ovarian, and gastric. Endometrial cancer is a malignancy that originates in the endometrium or the lining of the uterus. LS patients face a significantly elevated lifetime risk of endometrial cancer and experience a significantly younger age of onset compared to sporadic cases. Given this early onset, the classic presenting symptom of vaginal bleeding in endometrial cancer often proves unreliable for early detection. Endometrial biopsy (EMB) is recommended as a screening test every 1-2 years beginning at age 30-35 in LS patients; however, EMB can be associated with moderate to severe pain, which often deters patients from recommended surveillance. A menstrual cup is a small silicone device used to collect menstrual fluid, which includes blood and tissue. Menstrual blood contains a variety of cellular and non-cellular components that offer great value for the diagnosis of gynecologic cancers such as endometrial cancer. Menstrual cups may be an effective way to collect endometrial samples in LS patients.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07220239.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Jessica Diane St. Laurent
Phone: 617-632-0000
Dana-Farber Cancer InstituteStatus: Active
Contact: Jessica Diane St. Laurent
Phone: 617-632-0000
PRIMARY OBJECTIVES:
I. Assessing patient-reported outcomes and feasibility of the menstrual cup method in LS patients.
II. Comparing the pathological findings of endometrial cells from menstrual fluid and EMB.
SECONDARY OBJECTIVES:
I. To establish and characterize immunocompetent patient-derived organoids from LS carriers.
II. Optimizing protocols for reproducible organoid generation from both menstrual cup and EMB samples.
OUTLINE: Healthy volunteers are assigned to the pre-pilot study and LS patients are assigned to the main study.
PRE-PILOT STUDY: Participants insert menstrual cup over 4-12 hours prior to scheduled visit on day 1-7 of menstrual cycle bleeding in the absence of unacceptable toxicity. Participants then remove menstrual cup and undergo menstrual fluid cup sample collection during scheduled visit. Patients may undergo additional collections during the same or subsequent menstrual cycles at the discretion of the principal investigator.
MAIN STUDY: Patients undergo EMB during week 2-4 of menstrual cycle. Patients then insert menstrual cup over 4-12 hours prior to scheduled visit on day 1-7 of menstrual cycle bleeding in the absence of unacceptable toxicity. Patients then remove menstrual cup and undergo menstrual fluid cup sample collection during scheduled visit. Patients may undergo additional collections during the same or subsequent menstrual cycles at the discretion of the principal investigator.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJessica Diane St. Laurent
