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The overall goal of the project is to find a panel of novel biomarkers for early detection of ovarian torsion.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| confirmed ovarian torsion | immediately before laparoscopy and 1 day post- operation and four weeks after laparoscopy a panel of serum biomarkers will be tested |
| |
| confirmed non ovarian torsion | immediately before laparoscopy |
| |
| control group | match control Compare healthy controls with patients with or without ovarian torsion as confirmed by laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biomakers for ovarian torsion | Diagnostic Test | Blood biomarkers analysis using multiplex ELISA: The Luminex system is a magnetic bead-based multiplex ELISA that enable to measure simultaneously multiple proteins within the same sample. Human magnetic Luminex assay will be used for the following analytes: 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). Plasma samples stored at -70°C will be sent to accredited lab at BioTest (Israel) for performing the multiplex ELISA readout assay test using MagPix system. |
| Measure | Description | Time Frame |
|---|---|---|
| preoperative biochemical test -BIOMARKER PANEL FOR OVARIAN TORSION | Screen for elevation 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 years |
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Inclusion Criteria:
Exclusion criteria:
* Patients that are unable to provide informed consent
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Female patients between 12 and 50 years, who were admitted to the gynecological emergency room at Assuta medical center with signs and symptoms suggestive of ovarian torsion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oshri Barel, md | Contact | 972559382117 | oshrib@assuta.co.il | |
| Batel Hamou | Contact | 972522290708 | batel.hamou@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Batel Hamou, MD | Assuta Ashdod University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Ashdod University Hospital | Recruiting | Ashdod | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24480106 | Background | Swenson DW, Lourenco AP, Beaudoin FL, Grand DJ, Killelea AG, McGregor AJ. Ovarian torsion: Case-control study comparing the sensitivity and specificity of ultrasonography and computed tomography for diagnosis in the emergency department. Eur J Radiol. 2014 Apr;83(4):733-8. doi: 10.1016/j.ejrad.2014.01.001. Epub 2014 Jan 8. | |
| 11574515 |
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| ID | Term |
|---|---|
| D000082843 | Ovarian Torsion |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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Blood samples and peritoneal fluid samples
|
| peritoneal fluid proteins analysis | Diagnostic Test | Western blot for peritoneal fluid proteins analysis We will look for the relative abundance of proteins involved in the protection of cells against oxidative stress and the regulation of reactive oxygen species (ROS) using western blot. Superoxide dismutase 1 (SOD1, 16kDa) scavenges superoxides (O-2) within cells. Catalase (60kDa) is hydrogen peroxide (H2O2) scavenging enzyme regulate ROS concentrations within cells by reducing H202 into O2 and water. Thioredoxin (12kDa) facilitates the reduction of proteins via cysteine thiol-disulfide exchange. Alpha smooth muscle actin (42kDa) will be used as a loading control. These four proteins will be resolved by western blot given their different molecular weights using western blot cocktail antibodies (abcam # ab179843). |
|
| Assuta Ashdod University Hospital | Recruiting | Ashdod | Israel |
|
| Cohen SB, Wattiez A, Stockheim D, Seidman DS, Lidor AL, Mashiach S, Goldenberg M. The accuracy of serum interleukin-6 and tumour necrosis factor as markers for ovarian torsion. Hum Reprod. 2001 Oct;16(10):2195-7. doi: 10.1093/humrep/16.10.2195. |
| 24131677 | Background | Boaz M, Chernin G, Schwartz I, Katzir Z, Schwartz D, Agbaria A, Gal-Oz A, Weinstein T. C-reactive protein and carotid and femoral intima media thickness: predicting inflammation. Clin Nephrol. 2013 Dec;80(6):449-55. doi: 10.5414/CN108067. |
| 21242148 | Background | Kart C, Aran T, Guven S, Karahan SC, Yulug E. Acute increase in plasma D-dimer level in ovarian torsion: an experimental study. Hum Reprod. 2011 Mar;26(3):564-8. doi: 10.1093/humrep/deq378. Epub 2011 Jan 17. |
| 25591981 | Background | Guven S, Kart C, Guvendag Guven ES, Cetin EC, Mentese A. Is the measurement of serum ischemia-modified albumin the best test to diagnose ovarian torsion? Gynecol Obstet Invest. 2015;79(4):269-75. doi: 10.1159/000367787. Epub 2015 Jan 9. |
| 15051635 | Background | Khreiss T, Jozsef L, Potempa LA, Filep JG. Conformational rearrangement in C-reactive protein is required for proinflammatory actions on human endothelial cells. Circulation. 2004 Apr 27;109(16):2016-22. doi: 10.1161/01.CIR.0000125527.41598.68. Epub 2004 Mar 29. |
| 29984210 | Background | Uyanikoglu H, Hilali NG, Yardimciel M, Koyuncu I. A new biomarker for the early diagnosis of ovarian torsion: SCUBE-1. Clin Exp Reprod Med. 2018 Jun;45(2):94-99. doi: 10.5653/cerm.2018.45.2.94. Epub 2018 Jun 29. |
| 23164000 | Result | Piper HG, Oltmann SC, Xu L, Adusumilli S, Fischer AC. Ovarian torsion: diagnosis of inclusion mandates earlier intervention. J Pediatr Surg. 2012 Nov;47(11):2071-6. doi: 10.1016/j.jpedsurg.2012.06.011. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D014102 | Torsion Abnormality |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |