EndometriosisNCT04591548
Biomarkers in Endometriosis
An observational study of Endometriosis, run by University Medical Centre Ljubljana.
Trial summary
Endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Jan 2021
- How long will I take part?
- 1 Day
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with primary infertility or endometriosis with clinical indication for surgery.
Who may be able to join
- primary infertility
- normal semen analysis of the partner
- normal BMI.
Who cannot join
- hormonal therapy in the last year,
- irregular menstrual cycle,
- previous pelvic surgery,
- history of previous pelvic inflammatory disease,
- smokers and patients with autoimmune diseases,
- malignant or suspected malignant diseases,
- previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries
About this study
Endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. Results will be validate using ELISA aproach.
Read the detailed description
Informed consent will be obtained from all individual participants included in the study. Blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. Peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. The aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.
- Conditions
- Endometriosis
- Being tested
- proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample
- Keywords
- Endometriosis, Biomarkers
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sampleDiagnostic test
All samples were collected during laparoscopy, before any intraabdominal procedure was done. Indication for surgery was clinical (not for research purpose). All sample collection procedures was mimic regular clinical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | All patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery. Receives: Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample | |
| Primary infertility | All patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery. Receives: Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics
The aim of the study is to identify proteins with different levels in cases versus controls these proteins could be new candidates for biomarkers of endometriosis. Differentially expressed proteins are candidates for diagnostic and predictive biomarkers. To identify differentially expresed proteins in discovery phase of the study proteomic aproach will be used.
Measured: 3 years to collect all speciments
Secondary outcomes (1)
Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis
Using pairs of subjects with and without endometriosis, the derivation of the panel of proteins in body fluids (peritoneal fluid, peripheral blood, uterine fluid samples) gathered through proteomic aproach will be validated using ELISA.
Measured: 3 years to collect all speciments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 May 2016
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
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 University Medical Centre LjubljanaThe 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
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Vid Jansa, University Medical Centre Ljubljana
- Investigators
- Vid Jansa, MD, Principal investigator, UKCLjubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591548
- Sponsor's protocol ID
- BEND
- Status last verified
- Apr 2021
- First submitted
- 1 Aug 2020
- Last updated
- 27 Apr 2021
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Endometriosis
- ClinicalTrials.gov ID
- NCT04591548
- Acronym / sponsor ID
- BEND
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 19 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 common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. Results will be validate using ELISA aproach.
Detailed description
Informed consent will be obtained from all individual participants included in the study. Blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. Peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. The aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sampleAll patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery. |
| Primary infertility | – | Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sampleAll patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with primary infertility or endometriosis with clinical indication for surgery.
Key inclusion criteria (3 listed)
- primary infertility
- normal semen analysis of the partner
- normal BMI.
Key exclusion criteria (7 listed)
- hormonal therapy in the last year,
- irregular menstrual cycle,
- previous pelvic surgery,
- history of previous pelvic inflammatory disease,
- smokers and patients with autoimmune diseases,
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 |
|---|---|---|
| proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sampleAll samples were collected during laparoscopy, before any intraabdominal procedure was done. Indication for surgery was clinical (not for research purpose). All sample collection procedures was mimic regular clinical procedures. | Diagnostic test | Endometriosis, Primary infertility |
Primary outcome
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics
Time frame: 3 years to collect all speciments
The aim of the study is to identify proteins with different levels in cases versus controls these proteins could be new candidates for biomarkers of endometriosis. Differentially expressed proteins are candidates for diagnostic and predictive biomarkers. To identify differentially expresed proteins in discovery phase of the study proteomic aproach will be used.
1 secondary outcome
Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis
Time frame: 3 years to collect all speciments
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 27 Apr 2021.
- 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.
Vid Jansa, MD principal investigator
UKCLjubljana
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University Medical Centre Ljubljana.
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 7 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 27 Apr 2021. 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 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?
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics (time frame: 3 years to collect all speciments). 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 27 Apr 2021.