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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 : November 4, 2020
Sponsor:
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
Endometriosis

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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.
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.

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 ClinicalTrials.gov identifier (NCT number): NCT04598698


Contacts
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Contact: Alison Moe 415-236-3235 alison@dotlab.com

Locations
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United States, Illinois
The Advanced Gynecologic Surgery Institute Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Mary Johnston         
Sponsors and Collaborators
Dot Laboratories, Inc.
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Responsible Party: Dot Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT04598698    
Other Study ID Numbers: DL-001
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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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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Endometriosis