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Site for EMPOWER: Endometriosis diagnosis using MicroRNA: PrOspective study in Women to allow Early disease Recognition
This is a multi-center, observational study, the results of which will be used to support marketing for the intended use of the DotEndo investigational diagnostic. DotEndo is a non-invasive in vitro diagnostic test that measures levels of circulating miRNA biomarkers in whole blood. The DotEndo blood test will use a distinct classifier algorithm, based on levels of disease-specific miRNAs, to aid in the diagnosis of active endometriosis disease.
The study will enroll women 18 to 49 years old who have been referred to surgery for suspected endometriosis and other benign gynecological indications. Subjects will answer questionnaires and whole blood and saliva samples will be collected prior to and after surgery. Participation is expected to be approximately 3 months with some subjects continuing with annual follow-up post-surgery for 2 years.
Kaedryn DiGuglielmo at kdiguglielmo1@pennstatehealth.psu.edu or 717-531-1510
Female
18 year(s) or older
NCT04598698
Women's Health