The EMPOWER Study: Endometriosis Diagnosis Using microRNA

Sponsor

Dot Laboratories, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04598698

Collaborator

(none)

750

Enrollment

Locations

Anticipated Duration (Months)

32.6

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 2, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Hospital	Palo Alto	California	United States	94031
2	Center for Special Minimally Invasive & Robotic Surgery	Woodside	California	United States	94061
3	Yale University	New Haven	Connecticut	United States	06510
4	Christiana Care	Newark	Delaware	United States	19713
5	RAD Fertility	Newark	Delaware	United States	19713
6	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
7	University of South Florida	Tampa	Florida	United States	33606
8	Academia of Women's Health and Endoscopic Surgery	Atlanta	Georgia	United States	30328
9	Northwestern Medicine	Chicago	Illinois	United States	60611
10	NorthShore University HealthSystem	Evanston	Illinois	United States	60201
11	The Advanced Gynecologic Surgery Institute	Park Ridge	Illinois	United States	60068
12	University of Louisville Hospital	Louisville	Kentucky	United States	40202
13	Johns Hopkins University	Baltimore	Maryland	United States	21205
14	Rutgers Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08901
15	NewYork-Presbyterian / Columbia University Medical Center	New York	New York	United States	10019
16	University Hospitals	Cleveland	Ohio	United States	44106
17	Cleveland Clinic	Cleveland	Ohio	United States	44195
18	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
19	Penn State Health	Hershey	Pennsylvania	United States	17033
20	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
21	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
22	UT Austin	Austin	Texas	United States	78712
23	Seattle Reproductive Medicine	Seattle	Washington	United States	98109

Sponsors and Collaborators

Dot Laboratories, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dot Laboratories, Inc.

ClinicalTrials.gov Identifier:

NCT04598698

Other Study ID Numbers:

DL-001

First Posted:

Oct 22, 2020

Last Update Posted:

Jan 12, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Jan 12, 2022