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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
This study is NOT accepting healthy volunteers
NCT04598698
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Inclusion Criteria:
Women aged 18 to 49 years, inclusive,
Scheduled to undergo (within 30 days) either a) laparotomy or laparoscopy for signs and symptoms of suspected endometriosis or b) laparotomy, laparoscopy for another type of gynecologic procedure.
Willing and able to provide up to 50 mL of blood via venipuncture and comply with all other study and sample collection procedures
Exclusion Criteria:
History of surgically determined diagnosis of endometriosis
Is in a pre-menarchal or post-menopausal state, or has been rendered surgically menopausal
Is pregnant or has an active pelvic infection
Has an active malignancy
Is known to have HIV or Hepatitis A, B or C
Women's Health
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Location
Hershey, PA