Biomarker Panel in Ovarian Torsion

NCT05060120 | Unknown

• 1 other identifier: AAA-21-0094
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ovary Torsion; Adnexal Torsion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

confirmed ovarian torsion

immediately before laparoscopy and 1 day post- operation and four weeks after laparoscopy a panel of serum biomarkers will be tested

Diagnostic Test: biomakers for ovarian torsion; Diagnostic Test: peritoneal fluid proteins analysis

confirmed non ovarian torsion

immediately before laparoscopy

Diagnostic Test: biomakers for ovarian torsion

control group

match control Compare healthy controls with patients with or without ovarian torsion as confirmed by laparoscopy

Diagnostic Test: biomakers for ovarian torsion

Interventions

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.

confirmed non ovarian torsion; confirmed ovarian torsion; control group

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).

confirmed ovarian torsion

Eligibility Criteria

• Age: 12 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• Patients that will undergo laparoscopy for the diagnosis of ovarian torsion
• Able to provide informed consent for themselves or have a legal guardian that can provide informed consent (in cases of patients under 18 years old)

You may not qualify if:

• \* Patients that are unable to provide informed consent

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

Study Sites (2)

Assuta Ashdod University Hospital

Ashdod, Israel

RECRUITING

Assuta Ashdod University Hospital

Ashdod, Israel

RECRUITING

Related Publications (8)

• 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.

  PMID: 24480106 BACKGROUND

• 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.

  PMID: 11574515 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.

  PMID: 24131677 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.

  PMID: 21242148 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.

  PMID: 25591981 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.

  PMID: 15051635 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.

  PMID: 29984210 BACKGROUND

• 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.

  PMID: 23164000 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and peritoneal fluid samples

MeSH Terms

Conditions

Ovarian Torsion

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Torsion Abnormality; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Batel Hamou, MD

  Assuta Ashdod University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oshri Barel, md

CONTACT

972559382117; oshrib@assuta.co.il

Batel Hamou

CONTACT

972522290708; batel.hamou@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of gynecology unit

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 29, 2021
• Study Start: September 12, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)