The EMPOWER Study: Endometriosis Diagnosis Using microRNA (EMPOWER)

• ClinicalTrials.gov Identifier: NCT04598698
• Recruitment Status: Recruiting
• First Posted: October 22, 2020
• Last Update Posted: January 12, 2022
• Sponsor: Dot Laboratories, Inc.
• Information provided by (Responsible Party): Dot Laboratories, Inc.

Tracking Information

• First Submitted Date: October 16, 2020
• First Posted Date: October 22, 2020
• Last Update Posted Date: January 12, 2022
• Actual Study Start Date: November 2, 2020
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2020)

Clinical validity [ Time Frame: 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

Original Primary Outcome Measures (submitted: October 16, 2020)

Clinical validity [ Time Frame: From date of first sample collection to surgery, up to 3 weeks ]

To demonstrate the clinical validity of a microRNA (miRNA)-based assay to aid in the noninvasive diagnosis of endometriosis

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The EMPOWER Study: Endometriosis Diagnosis Using microRNA
• Official Title: Endometriosis Diagnosis Using microRNA: Prospective Study in Women to Allow Early Disease Recognition
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Endometriosis
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 16, 2020): 750
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Melissa Stosic; 203-212-8857; melissa@dotlab.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04598698
• Other Study ID Numbers: DL-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dot Laboratories, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Dot Laboratories, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Dot Laboratories, Inc.
• Verification Date: January 2022