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CompletedNCT05312528Updated Apr 5, 2022

Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis

An observational study in Endometriosis, sponsored by Bagcilar Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Bagcilar Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
79
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Endometriosis

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 79 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Bagcilar Training and Research Hospital is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic pelvic pain or suspected malignancy

Inclusion criteria

  1. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or suspected malignancy

Exclusion criteria

Exclusion Criteria:

  1. Malignant disease
  2. Ovarian failure
  3. Acute pelvic inflammatory disease
  4. Smokers
  5. Pregnancy
  6. Chronic autoimmune disease
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
79 participants (actual)
Patient registry
No

Groups and cohorts

  • Study Group

    Stage 3 and 4 endometriosis patients

    Procedure: endometriosis surgery

  • Control Group

    Patients without endometriosis, who required surgery for tubal ligation, benign ovarian cysts or uterine fibroids were included.

    Procedure: other benign condition surgeries

Interventions

  • Procedureendometriosis 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.

  • Procedureother benign condition surgeries

    ovarian cystectomy, bilateral tubal ligation, myomectomy etc.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 4 months

  2. 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.

    Time frame: Up to 4 months

  3. 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.

    Time frame: Up to 4 months

  4. 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.

    Time frame: Up to 4 months

  5. 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.

    Time frame: Up to 4 months

  6. 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.

    Time frame: Up to 4 months

07

Study locations

1 site
  • Bagcilar Teaching and Research Hospital
    Istanbul, Bagcilar 34200, Turkey
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05312528
Lead sponsor
Bagcilar Training and Research Hospital
Responsible party
Evrim Ebru Kovalak (Medical Doctor, Obstetrician and Gynecologist, Bagcilar Training and Research Hospital) — Principal investigator
First posted
Apr 5, 2022
Start date
Feb 1, 2018
Primary completion
Feb 1, 2019
Completion
Mar 1, 2019
Last update
Apr 5, 2022

Study contacts

Evrim Ebru Kovalak, MD
principal investigator · Bagcilar Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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