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The EMPOWER Study: Endometriosis Diagnosis Using microRNA (EMPOWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598698
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : January 12, 2022
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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