Biomarker Panel in Ovarian Torsion

Assuta Ashdod Hospital

Status: Enrolling

Conditions: Adnexal Torsion; Ovary Torsion

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

Study type: Observational

Funder types: Other

Identifiers

NCT05060120

AAA-21-0094

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 12 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 3 patient groups

confirmed ovarian torsion

Description:

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

Treatment:

Diagnostic Test: biomakers for ovarian torsion

Diagnostic Test: peritoneal fluid proteins analysis

confirmed non ovarian torsion

Description:

immediately before laparoscopy

Treatment:

Diagnostic Test: biomakers for ovarian torsion

control group

Description:

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

Treatment:

Diagnostic Test: biomakers for ovarian torsion