Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Procedure: endometriosis surgery; Procedure: other benign condition surgeries

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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Turkey
  • Bagcilar
    • Istanbul, Bagcilar, Turkey, 34200
      • Bagcilar Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Stage 3 and 4 endometriosis patients	Procedure: endometriosis 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.
Control Group; Patients without endometriosis, who required surgery for tubal ligation, benign ovarian cysts or uterine fibroids were included.	Procedure: other benign condition surgeries; ovarian cystectomy, bilateral tubal ligation, myomectomy etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Up to 4 months

Collaborators and Investigators

• Sponsor: Bagcilar Training and Research Hospital
• Investigators: Principal Investigator: Evrim Ebru Kovalak, MD, Bagcilar Training and Research Hospital

Publications and helpful links

General 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.

Helpful Links

• Based on the above publication

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (ACTUAL): April 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 2018.01.1.01.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No