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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. Identifier: NCT04598698
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : July 21, 2021
Information provided by (Responsible Party):
Dot Laboratories, Inc.

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

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Study Type : Observational
Estimated 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 : November 2, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04598698

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Contact: Alison Moe 415-236-3235

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United States, California
Stanford University Hospital Recruiting
Palo Alto, California, United States, 94031
Contact: Kathryn Batham         
United States, Delaware
RAD Fertility Recruiting
Newark, Delaware, United States, 19713
Contact: Eileen Davies         
Contact: Mark Modelski         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Melissa Gonzales         
United States, Georgia
Academia of Women's Health and Endoscopic Surgery Recruiting
Atlanta, Georgia, United States, 30328
Contact: Shirley Howell         
United States, Illinois
Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Jeremy Cornelius         
The Advanced Gynecologic Surgery Institute Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Mary Johnston         
United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Molly Brown         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Irene Trueheart         
United States, New York
NewYork-Presbyterian / Columbia University Medical Center Recruiting
New York, New York, United States, 10019
Contact: Reena Vattakalam         
United States, Ohio
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bridget Ermlich         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kathy Cummings         
United States, Pennsylvania
Penn State Health Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Heidi Watts         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Andrea Morley         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lori D'Ambrosio         
United States, Washington
Seattle Reproductive Medicine Recruiting
Seattle, Washington, United States, 98109
Contact: Anna Caldwell         
Contact: Robyn Davidson         
Sponsors and Collaborators
Dot Laboratories, Inc.
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Responsible Party: Dot Laboratories, Inc. Identifier: NCT04598698    
Other Study ID Numbers: DL-001
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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