The EMPOWER Study: Endometriosis Diagnosis Using microRNA

Endometriosis Clinical Trial

— EMPOWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598698
• Other study ID #: DL-001
• Status: Recruiting
• Start date: November 2, 2020
• Est. completion date: September 2024

Study information

• Verified date: January 2022
• Source: Dot Laboratories, Inc.
• Contact: Melissa Stosic
• Phone: 203-212-8857
• Email: melissa[@]dotlab.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: September 2024
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dot Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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