The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA

NCT04598698 | Active Not Recruiting

• 1 other identifier: Dot Laboratories DL-001
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 23

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

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.

Sponsors & Collaborators

• Dot Laboratories, Inc.: lead

Study Sites (23)

Stanford University Hospital

Palo Alto, California, 94031, United States

Location

Center for Special Minimally Invasive & Robotic Surgery

Woodside, California, 94061, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Christiana Care

Newark, Delaware, 19713, United States

Location

RAD Fertility

Newark, Delaware, 19713, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Academia of Women's Health and Endoscopic Surgery

Atlanta, Georgia, 30328, United States

Location

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

The Advanced Gynecologic Surgery Institute

Park Ridge, Illinois, 60068, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Rutgers Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

NewYork-Presbyterian / Columbia University Medical Center

New York, New York, 10019, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Penn State Health

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Austin

Austin, Texas, 78712, United States

Location

Seattle Reproductive Medicine

Seattle, Washington, 98109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: November 2, 2020
• Primary Completion: May 3, 2023
• Study Completion: December 1, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

US (23)