Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis

Sponsor

Bagcilar Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05312528

Collaborator

(none)

Enrollment

Location

12.9

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	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 Design

Study Type:

Observational

Actual Enrollment :

79 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Diagnostic value of serum Annexin V in endometriosis [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 [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 [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 [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 [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 [Up to 4 months]
To determine whether serum Interleukin-6 (pg/mL) levels can be used as diagnostic markers of endometriosis disease.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Malignant disease
Ovarian failure
Acute pelvic inflammatory disease
Smokers
Pregnancy
Chronic autoimmune disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bagcilar Teaching and Research Hospital	Istanbul	Bagcilar	Turkey	34200

Sponsors and Collaborators

Bagcilar Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Based on the above publication

Publications

None provided.

Responsible Party:

Evrim Ebru Kovalak, Medical Doctor, Obstetrician and Gynecologist, Bagcilar Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05312528

Other Study ID Numbers:

2018.01.1.01.001

First Posted:

Apr 5, 2022

Last Update Posted:

Apr 5, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Apr 5, 2022