The EMPOWER Study: Endometriosis Diagnosis Using microRNA (EMPOWER)
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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 |
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Recruitment Status :
Recruiting
First Posted : October 22, 2020
Last Update Posted : January 12, 2022
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Sponsor:
Dot Laboratories, Inc.
Information provided by (Responsible Party):
Dot Laboratories, Inc.
- Study Details
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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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| Endometriosis |
| 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 : | September 2022 |
| Estimated Study Completion Date : | September 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Endometriosis
Primary Outcome Measures :
- 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.
| 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:
- 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).
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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.
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
| Contact: Melissa Stosic | 203-212-8857 | melissa@dotlab.com |
Locations
Show 23 study locations
Sponsors and Collaborators
Dot Laboratories, Inc.
| 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: | January 12, 2022 |
| Last Verified: | January 2022 |
| 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 Genital Diseases, Female Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases |