EndometriosisS1P1NCT02973854
Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
An observational study of Endometriosis, run by St. Louis University at 1 site in United States.
Trial summary
Patients seen at the SLUCare Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study. Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed). Read more about this study
- Who is it for?
- Ages 13 to 55 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 10 Sep 2020
- 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 13 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients seen at the Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
Who may be able to join
- Patients seen at the Center for Endometriosis (including those with or without pain) who are undergoing excision surgery.
- Patients who are undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
- Completed a preoperative questionnaire
Who cannot join
- prior bilateral salpingo-oophorectomy
- post natural menopause
Trial locations and contacts
1 site in 1 country.
About this study
Patients seen at the SLUCare Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed).
After surgical excision has been performed, in order to provide standardized specimens for our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3 mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue will be sent to histology (SSM) for evaluation and classification as having endometriosis or not. For each patient in the study, blood will also be collected to look for markers for endometriosis.
Read the detailed description
The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for endometriosis on patients presenting with pain, infertility or both will be performed by the principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative and postoperative follow-up data on all patients recruited for this study based on comprehensive preoperative questionnaires, which includes data collection on pain scores (by VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The surgical approach in the treatment of endometriosis is by excision only, so that all lesions (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified at a histologic level, which is the gold standard way to diagnose the presence of endometriosis.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
S1PR1 levels in PBLs with and without endometriosis.
To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis.
Measured: At Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Yeung Jr., MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973854
- Sponsor's protocol ID
- 25996
- Acronym
- S1P1
- Status last verified
- Sep 2020
- First submitted
- 4 Oct 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
- ClinicalTrials.gov ID
- NCT02973854
- Acronym / sponsor ID
- S1P1 / 25996
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 25 Nov 2016 (estimated)
- 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.
Patients seen at the SLUCare Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed).
After surgical excision has been performed, in order to provide standardized specimens for our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3 mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue will be sent to histology (SSM) for evaluation and classification as having endometriosis or not. For each patient in the study, blood will also be collected to look for markers for endometriosis.
Detailed description
The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for endometriosis on patients presenting with pain, infertility or both will be performed by the principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative and postoperative follow-up data on all patients recruited for this study based on comprehensive preoperative questionnaires, which includes data collection on pain scores (by VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The surgical approach in the treatment of endometriosis is by excision only, so that all lesions (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified at a histologic level, which is the gold standard way to diagnose the presence of endometriosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients seen at the Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
Key inclusion criteria (3 listed)
- Patients seen at the Center for Endometriosis (including those with or without pain) who are undergoing excision surgery.
- Patients who are undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
- Completed a preoperative questionnaire
Key exclusion criteria (2 listed)
- prior bilateral salpingo-oophorectomy
- post natural menopause
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
S1PR1 levels in PBLs with and without endometriosis.
Time frame: At Surgery
To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis.
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 10 Sep 2020.
- Individual participant dataSharing planned: No
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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.
1 site 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 St. Louis University at 1 site 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 3 inclusion and 2 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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
S1PR1 levels in PBLs with and without endometriosis. (time frame: At 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 10 Sep 2020.