Clinical trial NCT04598698: The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA
Official title: Endometriosis Diagnosis Using MicroRNA: Prospective Study in Women to Allow Early Disease Recognition
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometriosis
Lead sponsor: Dot Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of reproductive age who have been referred to surgery for suspected endometriosis and other benign gynecological indications.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Participant is willing and able to provide written informed consent.
2. 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.
3. Participant is a female aged 18 through 49 years (inclusive).
4. Participant is scheduled to undergo:

   1. Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis. This shall constitute approximately 95% of the participants enrolled.
   2. 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.

Exclusion Criteria:

1. Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
2. 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.
3. Participant is pregnant.
4. Participant has an active malignancy.
5. Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
6. Participant has an active pelvic infection or other infections contraindicated for surgery.
7. Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug was or is planned to be administered.
8. Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.

Primary outcomes:
measure: Clinical validity
timeFrame: From date of first sample collection to surgery, up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Hospital
state: California
city: Woodside
country: United States
facility: Center for Special Minimally Invasive & Robotic Surgery
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Newark
country: United States
facility: RAD Fertility
state: Delaware
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Academia of Women's Health and Endoscopic Surgery
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Park Ridge
country: United States
facility: The Advanced Gynecologic Surgery Institute
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson University Hospital
state: New Jersey
city: New York
country: United States
facility: NewYork-Presbyterian / Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: UT Austin
state: Texas
city: Seattle
country: United States
facility: Seattle Reproductive Medicine
state: Washington
Study officials:
References: