EndometriosisEMPOWERNCT04598698
The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA
An observational study of Endometriosis, run by Dot Laboratories, Inc. at 23 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 750 participants
- Where
- 23 sitesUnited States
- Study dates
- 2 Nov 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women of reproductive age who have been referred to surgery for suspected endometriosis and other benign gynecological indications.
Who may be able to join
- 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).
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Academia of Women's Health and Endoscopic Surgery
Atlanta, Georgia, 30328
UT Austin
Austin, Texas, 78712
Johns Hopkins University
Baltimore, Maryland, 21205
Northwestern Medicine
Chicago, Illinois, 60611
University Hospitals
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
NorthShore University HealthSystem
Evanston, Illinois, 60201
Penn State Health
Hershey, Pennsylvania, 17033
University of Louisville Hospital
Louisville, Kentucky, 40202
Rutgers Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Yale University
New Haven, Connecticut, 06510
NewYork-Presbyterian / Columbia University Medical Center
New York, New York, 10019
Christiana Care
Newark, Delaware, 19713
RAD Fertility
Newark, Delaware, 19713
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Stanford University Hospital
Palo Alto, California, 94031
The Advanced Gynecologic Surgery Institute
Park Ridge, Illinois, 60068
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Seattle Reproductive Medicine
Seattle, Washington, 98109
University of South Florida
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Center for Special Minimally Invasive & Robotic Surgery
Woodside, California, 94061
About this study
Official title: Endometriosis Diagnosis Using MicroRNA: Prospective Study in Women to Allow Early Disease Recognition
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.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical validity
Performance of a microRNA (miRNA)-based assay compared to visual inspection during surgery for the diagnosis of active endometriosis
Measured: From date of first sample collection to surgery, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start2 Nov 2020
- Primary completion3 May 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dot Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598698
- Sponsor's protocol ID
- Dot Laboratories DL-001
- Acronym
- EMPOWER
- Status last verified
- Aug 2024
- First submitted
- 16 Oct 2020
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometriosis Diagnosis Using MicroRNA: Prospective Study in Women to Allow Early Disease Recognition
- ClinicalTrials.gov ID
- NCT04598698
- Acronym / sponsor ID
- EMPOWER / Dot Laboratories DL-001
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Dot Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women of reproductive age who have been referred to surgery for suspected endometriosis and other benign gynecological indications.
Key inclusion criteria (6 listed)
- 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).
- Participant is scheduled to undergo:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Dot Laboratories, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical validity (time frame: From date of first sample collection to surgery, up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.