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Completed

NCT Number: NCT05312528

Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endometriosis surgery

Procedure

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

Procedure

ovarian cystectomy, bilateral tubal ligation, myomectomy etc.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2022
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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