EndometriosisNCT04440397
Relationship Between Endoplasmic Reticulum Stress and Pain in Patients With Endometriosis
An observational study of Endometriosis and Endoplasmic Reticulum Stress, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Endoplasmic Reticulum Stress, Endometriosis-related Pain
- What is being tested?
- xbp-1 - endometriosis patients group
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Mar 2020to 4 Aug 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women between the ages of 18-50 who were diagnosed with endometriosis by ultrasound or surgery and who did not have any rheumatological and metaboli disease were included in the study. women with drug use indicated in the last 3 months were excluded from the study.
Who may be able to join
- diagnosed endometriosis with ultrasound or surgery
- no metabolic diseases
- no rheumatological diseases
Who cannot join
- Immune modulator, hormonal, anti-inflammatory use history in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoplasmic Reticulum Stress and Endometriosis Releated Pain
The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients. XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.
Read the detailed description
Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study. Most of the patients are composed of newly diagnosed patients.
- Being tested
- xbp-1 - endometriosis patients group
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xbp-1 - endometriosis patients groupOther
Patients diagnosed with endometriosis by surgery and ultrasound and whose xbp-1 level was examined
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis.
Measured: 5 months
Secondary outcomes (1)
serum XBP-1levels in patients wit endometriosis
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start17 Mar 2020
- Primary completion1 Aug 2020
- Study completion4 Aug 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-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440397
- Sponsor's protocol ID
- xbpendo
- Status last verified
- Aug 2020
- First submitted
- 17 Jun 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoplasmic Reticulum Stress and Endometriosis Releated Pain
- ClinicalTrials.gov ID
- NCT04440397
- Acronym / sponsor ID
- xbpendo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 19 Jun 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.
The correlation between painful symptoms (dysmenorrhea, dysparonia, dysuria, chronic pelvic pain) symptoms and endoplasmic reticulum stress was investigated in 86 patients diagnosed with endometriosis. For this, xbp-1 (x box binding protein-1) level was measured in patients. XBP-1 is an endoplasmic reticulum stress indicator and is known to be involved in pain pathogenesis.
Detailed description
Women between the ages of 18-50 who were diagnosed with endometriosis by surgery and ultrasound, without known rheumatological or metabolic diseases were included in the study. Most of the patients are composed of newly diagnosed patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women between the ages of 18-50 who were diagnosed with endometriosis by ultrasound or surgery and who did not have any rheumatological and metaboli disease were included in the study. women with drug use indicated in the last 3 months were excluded from the study.
Key inclusion criteria (3 listed)
- diagnosed endometriosis with ultrasound or surgery
- no metabolic diseases
- no rheumatological diseases
Key exclusion criteria (1 listed)
- Immune modulator, hormonal, anti-inflammatory use history in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xbp-1 - endometriosis patients groupPatients diagnosed with endometriosis by surgery and ultrasound and whose xbp-1 level was examined | Other | – |
Primary outcome
Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis.
Time frame: 5 months
1 secondary outcome
serum XBP-1levels in patients wit endometriosis
Time frame: 5 months
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 7 Aug 2020.
- Individual participant dataSharing planned: Yes
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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 and Endoplasmic Reticulum Stress, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 7 Aug 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 Turkey (Türkiye). 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?
Evaluation of the correlations between the results of XBP-1 levels and the stages and pain symptoms of endometriosis. (time frame: 5 months). 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 7 Aug 2020.