Endometrial Cancer study: Menstrual cup use
Official title Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
ClinicalTrials.gov ID: NCT07220239
What this study is testing
- What it's testing
- The study aims to see whether a menstrual cup can gather enough endometrial tissue for examination, compare it to standard biopsies, and assess comfort and feasibility.
- Who it's for
- Women who have Lynch syndrome and are at higher risk for endometrial cancer.
- What's involved
- Participants will use a menstrual cup at home to collect menstrual blood and also undergo a routine endometrial biopsy by a healthcare provider. They will then complete a short survey about the cup’s ease and comfort.
- Time commitment
- The study involves a single menstrual cup collection, one clinic visit for the biopsy, and a brief survey, all within a short time frame.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pre-pilot study
- Individuals over the age of 18
- Menstruating
You likely can't join if
- 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
See the full eligibility criteria
- Pre-pilot study
- Individuals over the age of 18
- Menstruating
- 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
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.