EndometriosisNCT05312528
Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis
An observational study of Endometriosis, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep infiltrating endometriosis, their levels in organ-specific involvement, their relationship with symptoms, and the changes of these markers in… 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
- What is being tested?
- endometriosis surgery and other benign condition surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Mar 2019
- 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: Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic pelvic pain or suspected malignancy
Who may be able to join
- 1. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or suspected malignancy
Who cannot join
- Malignant disease
- Ovarian failure
- Acute pelvic inflammatory disease
- Smokers
- Pregnancy
- Chronic autoimmune disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Teaching and Research Hospital
Istanbul, Bagcilar, 34200
About this study
Official title: Diagnostic Value of Annexin V, sVCAM-1, sICAM-1, Vascular Endothelial Growth Factor, TNF Alpha and Interleukin-6 in Ovarian and Deep Infiltrating Endometriosis, the Changes of These Markers in the Postoperative Period
The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep infiltrating endometriosis, their levels in organ-specific involvement, their relationship with symptoms, and the changes of these markers in the postoperative period will be evaluated.
Read the detailed description
Serum Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and proinflammatory cytokines (TNF-a and interleukin-6) values were studied by taking blood samples from all patients before and three months after the operation.
- Conditions
- Endometriosis
- Being tested
- endometriosis surgery, other benign condition surgeries
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometriosis surgeryProcedure or surgery
Laparoscopy was performed in the follicular phase of the woman's menstrual cycle and all recognizable endometriotic lesions were treated by bipolar coagulation, resection of endometriotic nodules and ovarian cystectomy.
other benign condition surgeriesProcedure or surgery
ovarian cystectomy, bilateral tubal ligation, myomectomy etc.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Stage 3 and 4 endometriosis patients Receives: Procedure: endometriosis surgery | |
| Control Group | Patients without endometriosis, who required surgery for tubal ligation, benign ovarian cysts or uterine fibroids were included. Receives: Procedure: other benign condition surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of serum Annexin V in endometriosis
To determine whether serum Annexin V levels (ng/mL) can be used as diagnostic markers of endometriosis disease.
Measured: Up to 4 months
Diagnostic value of serum sVCAM-1 in endometriosis
To determine whether serum sVCAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.
Measured: Up to 4 months
Diagnostic value of serum sICAM-1 in endometriosis
To determine whether serum sICAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.
Measured: Up to 4 months
Diagnostic value of serum Vascular Endothelial Growth Factor in endometriosis
To determine whether serum Vascular Endothelial Growth Factor (pg/mL) levels can be used as diagnostic markers of endometriosis disease.
Measured: Up to 4 months
Diagnostic value of serum TNF-alpha in endometriosis
To determine whether serum TNF-alpha (pg/mL) levels can be used as diagnostic markers of endometriosis disease.
Measured: Up to 4 months
Diagnostic value of serum Interleukin-6 in endometriosis
To determine whether serum Interleukin-6 (pg/mL) levels can be used as diagnostic markers of endometriosis disease.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Feb 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Evrim Ebru Kovalak, Bagcilar Training and Research Hospital
- Investigators
- Evrim Ebru Kovalak, MD, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312528
- Sponsor's protocol ID
- 2018.01.1.01.001
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vodolazkaia A, El-Aalamat Y, Popovic D, Mihalyi A, Bossuyt X, Kyama CM, Fassbender A, Bokor A, Schols D, Huskens D, Meuleman C, Peeraer K, Tomassetti C, Gevaert O, Waelkens E, Kasran A, De Moor B, D'Hooghe TM. Evaluation of a panel of 28 biomarkers for the non-invasive diagnosis of endometriosis. Hum Reprod. 2012 Sep;27(9):2698-711. doi: 10.1093/humrep/des234. Epub 2012 Jun 26.
PubMed 22736326
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Annexin V, sVCAM-1, sICAM-1, Vascular Endothelial Growth Factor, TNF Alpha and Interleukin-6 in Ovarian and Deep Infiltrating Endometriosis, the Changes of These Markers in the Postoperative Period
- ClinicalTrials.gov ID
- NCT05312528
- Acronym / sponsor ID
- 2018.01.1.01.001
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Apr 2022 (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 diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep infiltrating endometriosis, their levels in organ-specific involvement, their relationship with symptoms, and the changes of these markers in the postoperative period will be evaluated.
Detailed description
Serum Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and proinflammatory cytokines (TNF-a and interleukin-6) values were studied by taking blood samples from all patients before and three months after the operation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Procedure: endometriosis surgeryStage 3 and 4 endometriosis patients |
| Control Group | – | Procedure: other benign condition surgeriesPatients without endometriosis, who required surgery for tubal ligation, benign ovarian cysts or uterine fibroids were included. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic pelvic pain or suspected malignancy
Key inclusion criteria (1 listed)
- 1. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or suspected malignancy
Key exclusion criteria (6 listed)
- Malignant disease
- Ovarian failure
- Acute pelvic inflammatory disease
- Smokers
- Pregnancy
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 |
|---|---|---|
| endometriosis surgeryLaparoscopy was performed in the follicular phase of the woman's menstrual cycle and all recognizable endometriotic lesions were treated by bipolar coagulation, resection of endometriotic nodules and ovarian cystectomy. | Procedure or surgery | Study Group |
| other benign condition surgeriesovarian cystectomy, bilateral tubal ligation, myomectomy etc. | Procedure or surgery | Control Group |
Primary outcome
Diagnostic value of serum Annexin V in endometriosis
Time frame: Up to 4 months
To determine whether serum Annexin V levels (ng/mL) can be used as diagnostic markers of endometriosis disease.
Diagnostic value of serum sVCAM-1 in endometriosis
Time frame: Up to 4 months
To determine whether serum sVCAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.
Diagnostic value of serum sICAM-1 in endometriosis
Time frame: Up to 4 months
To determine whether serum sICAM-1(ng/mL) levels can be used as diagnostic markers of endometriosis disease.
Diagnostic value of serum Vascular Endothelial Growth Factor in endometriosis
Time frame: Up to 4 months
To determine whether serum Vascular Endothelial Growth Factor (pg/mL) levels can be used as diagnostic markers of endometriosis disease.
Diagnostic value of serum TNF-alpha in endometriosis
Time frame: Up to 4 months
To determine whether serum TNF-alpha (pg/mL) levels can be used as diagnostic markers of endometriosis disease.
Diagnostic value of serum Interleukin-6 in endometriosis
Time frame: Up to 4 months
To determine whether serum Interleukin-6 (pg/mL) levels can be used as diagnostic markers of endometriosis disease.
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 5 Apr 2022.
- Results publication: PubMed 22736326Vodolazkaia A, El-Aalamat Y, Popovic D, Mihalyi A, Bossuyt X, Kyama CM, Fassbender A, Bokor A, Schols D, Huskens D, Meuleman C, Peeraer K, Tomassetti C, Gevaert O, Waelkens E, Kasran A, De Moor B, D'Hooghe TM. Evaluation of a panel of 28 biomarkers for the non-invasive diagnosis of endometriosis. Hum Reprod. 2012 Sep;27(9):2698-711. doi: 10.1093/humrep/des234. Epub 2012 Jun 26.
- Based on the above publicationLink provided by the sponsor.
- 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.
Evrim Ebru Kovalak, MD principal investigator
Bagcilar Training and Research Hospital
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 Bagcilar 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 1 inclusion and 6 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 5 Apr 2022. 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?
Diagnostic value of serum Annexin V in endometriosis (time frame: Up to 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312528, which also lists 1 linked publication.
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 Apr 2022.