EndometriosisNCT03161704
Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
An observational study of Endometriosis, run by Yale University at 5 sites in United States.
Trial summary
This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 114 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Jul 2016to Dec 2019
- How long will I take part?
- 3 Months
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females aged 18-44 who are scheduled to undergo gynecologic surgery (laparoscopy/laparotomy). Indications for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
Who may be able to join
- Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).
- Indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
Who cannot join
- • Currently pregnant
- Current or past diagnosis of any malignancy (with the exception of non-melanoma skin cancer)
- Known to be HIV-positive
- Unable to give informed consent
- Unwillingness to have samples banked in Repository for future use
- Clinical evidence of active cervical infection
Show all 11Show fewer
- Lupron (or other GRH agonist) therapy within the last 2 months (or Depo-Lupron within the last 4 months)
- Current use of estrogen or progestin (oral, transdermal, intrauterine or ring).
- o Current use is defined as use in the index menstrual cycle (since the onset of the last menstrual period).
- Use of depo estrogen or progestin in last 3 months
- Current use of aromatase inhibitor
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Augusta University
Augusta, Georgia, 30912
Pennsylvania State University
Hershey, Pennsylvania, 17033
Yale University
New Haven, Connecticut, 06520
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Wayne State University
Southfield, Michigan, 48034
About this study
This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery. The investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of up to 3 2cm samples of Endometrial Tissue
Up to 3 2cm samples will be collected per collection.
Measured: 2 collection timepoints: baseline and up to 18 weeks following surgery.
Secondary outcomes (2)
Collection of Serum 1 will be 2 10ml serum tubes of serum
2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection.
Measured: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Collection of Serum 2 will be 2 7 ml serum tubes of serum
2 7ml serum tubes drawn at each collection, up to 10 1.0ml aliquots of serum plus 1 15ml conical tube with the 2 blood clots per collection.
Measured: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start8 Jul 2016
- Primary completionAug 2019
- Study completionDec 2019
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University, Penn State University, University of California, San Francisco, University of North Carolina, University of Oklahoma, University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kurt Barnhart, MD MSCE, Principal investigator, University of PennsylvaniaEsther Eisenberg, MD MPH, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Nanette Santoro, MD, Study chair, University of Colorado, DenverMichael Diamond, MD, Principal investigator, Augusta UniversityRichard Legro, MD, Principal investigator, Milton S. Hershey Medical CenterMarcelle Cedars, MD, Principal investigator, University of California, San FranciscoAnne Steiner, MD MPH, Principal investigator, University of North CarolinaKarl Hansen, MD PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161704
- Sponsor's protocol ID
- ENDOmarker
- Status last verified
- Jan 2020
- First submitted
- 13 Nov 2015
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
- ClinicalTrials.gov ID
- NCT03161704
- Acronym / sponsor ID
- ENDOmarker
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Augusta University, Penn State University, University of California, San Francisco, University of North Carolina, University of Oklahoma, University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 May 2017 (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.
This study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery. The investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females aged 18-44 who are scheduled to undergo gynecologic surgery (laparoscopy/laparotomy). Indications for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
Key inclusion criteria (2 listed)
- Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).
- Indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
Key exclusion criteria (11 listed)
- • Currently pregnant
- o Current use is defined as use in the index menstrual cycle (since the onset of the last menstrual period).
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
Collection of up to 3 2cm samples of Endometrial Tissue
Time frame: 2 collection timepoints: baseline and up to 18 weeks following surgery.
Up to 3 2cm samples will be collected per collection.
2 secondary outcomes
Collection of Serum 1 will be 2 10ml serum tubes of serum
Time frame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Collection of Serum 2 will be 2 7 ml serum tubes of serum
Time frame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Kurt Barnhart, MD MSCE principal investigator
University of Pennsylvania
Esther Eisenberg, MD MPH study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD study chair
University of Colorado, Denver
5 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 Yale University at 5 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Collection of up to 3 2cm samples of Endometrial Tissue (time frame: 2 collection timepoints: baseline and up to 18 weeks following surgery.). 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 6 Jan 2020.