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Clinical Trial Summary

The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.


Clinical Trial Description

The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion. The specifc aims of the current study are: 1. Screen for changes in blood protein biomarkers concentrations specifc for patients with ovarian torsion. The biomarkers are: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml). 2. Compare the amount of oxidative stress defense proteins SOD1, Catalase, and Thioredoxin amount in the peritoneal fluid wash between patients with or without confirmed ovarian torsion. To our knowledge, this is the first study that specifically evaluates the expression of oxidation stress defense proteins in ovarian torsion. The results will enable us to decide whether to include oxidation stress biomarkers within the panel. 3. Study population methodology and techniques A prospective, 12-24 months study. 20 Patients with confirmed ovarian torsion will be enrolled. The patients will complete a questionnaire prior to and following the procedure 3.5ml blood samples will be obtained immediately before laparoscopy, postoperative day, and four weeks after laparoscopy during the follow-up. The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure. 20 Patients suspected of ovarian torsion with no ovarian torsion, as confirmed by laparoscopy, will be enrolled. The patients will complete a questionnaire prior to and following the procedure 5ml blood samples will be obtained immediately before laparoscopy and four weeks after laparoscopy during the follow-up. The peritoneal fluid wash will be collected during the laparoscopy from 14 patients (out of the 20 enrolled) that will provide additional written consent specific for the procedure. 20 Healthy controls will be enrolled and provide a 5ml blood sample. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05060120
Study type Observational
Source Assuta Ashdod Hospital
Contact Oshri Barel, md
Phone 972559382117
Email [email protected]
Status Recruiting
Phase
Start date September 12, 2021
Completion date August 2024

See also
  Status Clinical Trial Phase
Recruiting NCT01659489 - ADnexal TOrsion Markers Study N/A
Recruiting NCT04522219 - Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion N/A