Biomarker Panel in Ovarian Torsion

September 17, 2021 updated by: Oshri Barell, Assuta Ashdod Hospital

Biomarker Panel for Early Diagnosis of Ovarian Torsion

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ashdod, Israel
        • Recruiting
        • Assuta Ashdod University Hospital
        • Contact:
        • Sub-Investigator:
          • Oshri Barel, MD
        • Principal Investigator:
          • Batel Hamou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

Inclusion Criteria:

  • 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)

Exclusion criteria:

* Patients that are unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: peritoneal fluid proteins analysis

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 non ovarian torsion
immediately before laparoscopy
Diagnostic test: biomakers for ovarian torsion
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.
control group
match control Compare healthy controls with patients with or without ovarian torsion as confirmed by laparoscopy
Diagnostic test: biomakers for ovarian torsion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preoperative biochemical test -BIOMARKER PANEL FOR OVARIAN TORSION
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Ashdod Hospital

Investigators

  • Principal Investigator: Batel Hamou, MD, Assuta Ashdod University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAA-21-0094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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