The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA

Running, not enrolling

Conditions studied: Endometriosis

In brief

Endometriosis is a complex, heterogeneous disease that may present inconsistently across women. Using disease-specific biomarkers and advanced biostatistics, DotLab is developing a biomarker test to confirm the presence of endometriosis.This is a multi-center, prospective, observational, minimal risk study in women undergoing laparoscopy, laparotomy or other pelvic surgical procedure for endometriosis, infertility or another benign gynecological indication. Participants will undergo 2 study visits for collection of blood and saliva and completion of study questionnaires.

Key facts

Study ID

NCT04598698

Run by

Dot Laboratories, Inc.

People needed

750

Starts

2020-11-02

Expected to finish

2024-12-01

Last updated by the study team

2024-08-30

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Participant is willing and able to provide written informed consent.
• Participant is willing and able to provide up to 50 mL of blood via venipuncture and comply with all other study and sample collection procedures.
• Participant is a female aged 18 through 49 years (inclusive).
• Participant is scheduled to undergo:
• Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis. This shall constitute approximately 95% of the participants enrolled.
• Laparotomy, laparoscopy, or other procedures including, but not limited to, tubal ligation, lysis of adhesions, hysterectomy for benign condition, myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy for indications including, but not limited to, infertility or benign gynecological indications (e.g., benign pelvic masses, infertility, abnormal uterine bleeding). This shall constitute approximately 5% of the participants enrolled.

You may not qualify if…

• Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
• Participant is a female in a pre-menarchal or post-menopausal state (last menstrual period at least 1 year before Screening and no other biological or physiological cause can be identified) or has been rendered surgically menopausal (bilateral oophorectomy) for at least 6 months at Screening.
• Participant is pregnant.
• Participant has an active malignancy.
• Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
• Participant has an active pelvic infection or other infections contraindicated for surgery.
• Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug was or is planned to be administered.
• Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.

Where it is running

• Stanford University Hospital — Palo Alto, California, United States
• Center for Special Minimally Invasive & Robotic Surgery — Woodside, California, United States
• Yale University — New Haven, Connecticut, United States
• Christiana Care — Newark, Delaware, United States
• RAD Fertility — Newark, Delaware, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of South Florida — Tampa, Florida, United States
• Academia of Women's Health and Endoscopic Surgery — Atlanta, Georgia, United States
• Northwestern Medicine — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• The Advanced Gynecologic Surgery Institute — Park Ridge, Illinois, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Rutgers Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• NewYork-Presbyterian / Columbia University Medical Center — New York, New York, United States
• University Hospitals — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Penn State Health — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• UT Austin — Austin, Texas, United States
• Seattle Reproductive Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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