Trial NCT07220239
Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome
- Phase
- Not given
- Sponsor
- Jessica D. St. Laurent, MD
- Conditions
- Endometrial Cancer; Lynch Syndrome; Screening; Early Detection of Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 cancerPrior malignancy 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 pregnancyPregnancy
* 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)
Restrictions found (2)
- PregnancyOutrightexclusionShow in the text
- Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County