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NCT05312528 Clinical Trial

Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05312528
Other study ID # 2018.01.1.01.001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date March 1, 2019

Study information
Verified date March 2022
Source Bagcilar Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 the postoperative period will be evaluated.

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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date March 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• other benign condition surgeries
ovarian cystectomy, bilateral tubal ligation, myomectomy etc.

Locations
Country Name City State
Turkey Bagcilar Teaching and Research Hospital Istanbul Bagcilar

Sponsors (1)
Lead Sponsor Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 th — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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