Clinical trial NCT05060120: Biomarker Panel in Ovarian Torsion
Official title: Biomarker Panel for Early Diagnosis of Ovarian Torsion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovary Torsion
Adnexal Torsion
Lead sponsor: Assuta Ashdod Hospital
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: preoperative biochemical test -BIOMARKER PANEL FOR OVARIAN TORSION
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod University Hospital
city: Ashdod
country: Israel
facility: Assuta Ashdod University Hospital
Study officials:
affiliation: Assuta Ashdod University Hospital
name: Batel Hamou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.