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History of Changes for Study: NCT04598698
The EMPOWER Study: Endometriosis Diagnosis Using microRNA (EMPOWER)
Latest version (submitted January 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 16, 2020 None (earliest Version on record)
2 October 21, 2020 Outcome Measures and Study Status
3 November 2, 2020 Recruitment Status, Study Status and Contacts/Locations
4 February 5, 2021 Contacts/Locations and Study Status
5 February 9, 2021 Study Status and Contacts/Locations
6 February 25, 2021 Contacts/Locations and Study Status
7 April 21, 2021 Contacts/Locations and Study Status
8 June 2, 2021 Study Status and Contacts/Locations
9 June 22, 2021 Contacts/Locations and Study Status
10 July 19, 2021 Study Status and Contacts/Locations
11 November 15, 2021 Study Status and Contacts/Locations
12 January 5, 2022 Contacts/Locations and Study Status
13 January 11, 2022 Contacts/Locations and Study Status
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Study NCT04598698
Submitted Date:  October 16, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: DL-001
Brief Title: The EMPOWER Study: Endometriosis Diagnosis Using microRNA (EMPOWER)
Official Title: Endometriosis Diagnosis Using microRNA: Prospective Study in Women to Allow Early Disease Recognition
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Not yet recruiting
Study Start: October 2020
Primary Completion: May 2022 [Anticipated]
Study Completion: February 2024 [Anticipated]
First Submitted: October 16, 2020
First Submitted that
Met QC Criteria:
October 16, 2020
First Posted: October 22, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 16, 2020
Last Update Posted: October 22, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Dot Laboratories, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Endometriosis
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 750 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Open or close this module Eligibility
Study Population: Women of reproductive age who have been referred to surgery for suspected endometriosis and other benign gynecological indications.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age: 49 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Alison Moe
Telephone: 415-236-3235
Email: alison@dotlab.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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