The EMPOWER Study: Endometriosis Diagnosis Using microRNA (EMPOWER)

Endometriosis Diagnosis Using microRNA: Prospective Study in Women to Allow Early Disease Recognition

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

• Study Contact: Name: Melissa Stosic; Phone Number: 203-212-8857; Email: melissa@dotlab.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94031
      • Recruiting
      • Stanford University Hospital
      • Contact: Kathryn Batham
    • Woodside, California, United States, 94061
      • Recruiting
      • Center for Special Minimally Invasive & Robotic Surgery
      • Contact: Reanette Karan
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University
      • Contact: Michele Jasne
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Christiana Care
      • Contact: Amy Staples
    • Newark, Delaware, United States, 19713
      • Recruiting
      • RAD Fertility
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
      • Contact: Melissa Gonzales
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida
      • Contact: Katherine Lin
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • Academia of Women's Health and Endoscopic Surgery
      • Contact: Katherine Gomez
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine
      • Contact: Jeremy Cornelius
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • Northshore University Healthsystem
      • Contact: Ellen Garrison
      • Contact: Sarah Darnell
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • The Advanced Gynecologic Surgery Institute
      • Contact: Mary Johnston
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Hospital
      • Contact: Molly Brown
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins University
      • Contact: Melissa Saulynas
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Robert Wood Johnson University Hospital
      • Contact: Allison Cabinian
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • NewYork-Presbyterian / Columbia University Medical Center
      • Contact: Reena Vattakalam
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Sheila Woodruff
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals
      • Contact: Bridget Ermlich
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma Health Sciences Center
      • Contact: Kathy Cummings
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Active, not recruiting
      • Penn State Health
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Andrea Morley
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Lori D'Ambrosio
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • UT Austin
      • Contact: Elizabeth Davis
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Seattle Reproductive Medicine
      • Contact: Anna Caldwell
      • Contact: Robyn Davidson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical validity	Performance of a microRNA (miRNA)-based assay compared to visual inspection during surgery for the diagnosis of active endometriosis	From date of first sample collection to surgery, up to 3 weeks

Collaborators and Investigators

• Sponsor: Dot Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2020
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: DL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No