Chronic Pelvic PainEMBARKNCT03272360
Endometriosis Biomarker Discovery Study
An observational study of Chronic Pelvic Pain and Endometriosis, run by Myriad Genetic Laboratories, Inc..
Trial summary
This is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Pelvic Pain, Endometriosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jun 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women seeking care at OB/GYN clinics and fertility centers
Who may be able to join
- Able to give informed consent.
- Aged 18-45 years old who has a regular menstrual cycle (26 to 32 days in length).
- Undergoing a planned diagnostic or therapeutic laparoscopy for the indication of pelvic pain or for elective tubal ligation.
- One prior pregnancy for tubal ligation patients.
Who cannot join
- Prior surgical diagnosis of endometriosis.
- Currently pregnant or breastfeeding.
- Clinical suspicion of pelvic inflammatory disease (PID) or urinary tract infection.
- Current malignancy except non-melanoma skin cancer adequately treated.
- Known major systemic disease, including but not limited to inflammatory disease, autoimmune disease.
- Use of immunosuppressants in the past 3 months.
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- Use of injectable reproductive hormonal therapy within the past 3 months and have not menstruated since last dose.
- If reproductive hormonal implant has been used in the past, it must have been removed > 3 months prior to study entry and subject must have menstruated since removal.
- Use of intrauterine device (IUD) in the past 3 months.
- Use of any other reproductive hormone therapy within the past 3 months, except for oral contraceptives (OCPs).
About this study
Official title: A Prospective Sample Collection Study in Patients With Pelvic Pain Undergoing Laparoscopy for Biomarker Identification in Endometriosis
This is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue samples at the time of laparoscopy.
Read the detailed description
This study will be a prospective collection of blood, urine, and endometrial tissue from women with chronic pelvic pain symptoms, with or without infertility, who require evaluation by laparoscopy. Women undergoing laparoscopy for elective tubal ligation will also be investigated similarly and serve as the negative control. Subjects will be queried regarding sociodemographic characteristics, medical and reproductive history, pain and lifestyle as well as assessment for differential diagnoses such as interstitial cystitis and idiopathic bowel syndrome. Endometriosis severity will be captured by rASRM staging during laparoscopy.
- Conditions
- Chronic Pelvic Pain, Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pelvic Pain | Not described | |
| Elective Tubal Ligation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain
The primary variables will be the DiscoveryMAP analytes identified in blood and/or urine and the mRNA transcriptome in endometrial tissue. DiscoveryMAP is a comprehensive, quantitative platform of immunoassays evaluating multiple analytes in various body system categories: cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and cancer markers
Measured: Baseline (pre-operative)
Secondary outcomes (1)
The identification of biomarker(s) that are associated with endometriosis severity
The secondary variables will be measures of endometriosis severity: rASRM staging of endometriosis and pain severity from clinical survey
Measured: Baseline (pre-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study startSep 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: company decision to suspend project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272360
- Sponsor's protocol ID
- EP-002
- Acronym
- EMBARK
- Status last verified
- Sep 2016
- First submitted
- 6 Sep 2016
- Last updated
- 5 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Sample Collection Study in Patients With Pelvic Pain Undergoing Laparoscopy for Biomarker Identification in Endometriosis
- ClinicalTrials.gov ID
- NCT03272360
- Acronym / sponsor ID
- EMBARK / EP-002
- Conditions
- Chronic Pelvic Pain, Endometriosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: company decision to suspend project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 Sep 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 is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue samples at the time of laparoscopy.
Detailed description
This study will be a prospective collection of blood, urine, and endometrial tissue from women with chronic pelvic pain symptoms, with or without infertility, who require evaluation by laparoscopy. Women undergoing laparoscopy for elective tubal ligation will also be investigated similarly and serve as the negative control. Subjects will be queried regarding sociodemographic characteristics, medical and reproductive history, pain and lifestyle as well as assessment for differential diagnoses such as interstitial cystitis and idiopathic bowel syndrome. Endometriosis severity will be captured by rASRM staging during laparoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Pelvic Pain | – | – |
| Elective Tubal Ligation | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women seeking care at OB/GYN clinics and fertility centers
Key inclusion criteria (4 listed)
- Able to give informed consent.
- Aged 18-45 years old who has a regular menstrual cycle (26 to 32 days in length).
- Undergoing a planned diagnostic or therapeutic laparoscopy for the indication of pelvic pain or for elective tubal ligation.
- One prior pregnancy for tubal ligation patients.
Key exclusion criteria (10 listed)
- Prior surgical diagnosis of endometriosis.
- Currently pregnant or breastfeeding.
- Clinical suspicion of pelvic inflammatory disease (PID) or urinary tract infection.
- Current malignancy except non-melanoma skin cancer adequately treated.
- Known major systemic disease, including but not limited to inflammatory disease, autoimmune disease.
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
The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain
Time frame: Baseline (pre-operative)
The primary variables will be the DiscoveryMAP analytes identified in blood and/or urine and the mRNA transcriptome in endometrial tissue. DiscoveryMAP is a comprehensive, quantitative platform of immunoassays evaluating multiple analytes in various body system categories: cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and cancer markers
1 secondary outcome
The identification of biomarker(s) that are associated with endometriosis severity
Time frame: Baseline (pre-operative)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pelvic Pain and Endometriosis, run by Myriad Genetic Laboratories, Inc..
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain (time frame: Baseline (pre-operative)). 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 5 Sep 2017.